FDA Warning Letters This Week 3/1/17


The week goes by and new letters come out. Looks like we’ve only got one food letter this week so let’s get into it.

Don’t know what warning letters are? Check out this post for a brief overview of what they are and why FDA sends them out.

WL# CMS Case 517876 (man, they really aren’t consistent with this numbering system, are they?)

Subject: Seafood HACCP/CGMP for foods/adulterated/insanitary conditions

Our first finding here is once again a failure to follow the seafood HACCP requirements. As we’ve discussed on this blog before, companies that produce Juice and Seafood have specific critical control points and HACCP plans spelled out in the regulations. Oftentimes small companies or importers who have never been inspected, or were never aware of what their requirements were, violate or do not put these programs in place. Because this is considered an imminent threat to food safety, FDA almost always issues a warning letter. Most of what you see are companies that just straight up don’t have the programs in place, rather than specific violations.

This particular firm falls into this category, and we’ll see from the responses they already provided to FDA in this warning letter that they clearly don’t have someone on staff familiar with the regulations required of them, or a genuine appreciation for the ones that actively protect food safety. FDA noted that the HACCP finding is based on the fact that the company simply didn’t have one for the product. It’s possible that because the name of the company doesn’t imply that it manufactures a lot of seafood (check the warning letter to see what I mean), they may have started making this ingredient recently before fully understanding what was required of them. This doesn’t change the fact that the firm demonstrated poor understanding of certain food safety and regulatory requirements in general. For example, in response to not having the HACCP plan, they told FDA that they would look into it in response.

FDA said ‘lol, no’, you can’t just keep making food outside of a critical food safety regulation until you decide to get around to it.

In your letter, you agree that your firm has no HACCP plan in place.  You included a statement that you will seek “further information regarding obtaining this HACCP plan” for your firm; however, your response is not adequate. You did not provide a timeframe of when a HACCP plan will be established and implemented, and your response does not provide assurances that your firm will process this product under an adequate HACCP plan.

This “HACCP Plan”

We’ll look into this “HACCP plan” thingy, whatever it may be, is not an adequate response. The firm violated a spelled out regulatory requirement, required to produce seafood products safely, and the fact that they had no idea what it was means demonstrated that that there isn’t any regulatory review or knowledge at the plant. Either this changes after this wake-up call, or FDA will eventually stop them from selling seafood having seen no effort made to be in compliance.

If you are interested in HACCP, I’ll probably cover many basic principles throughout this blog, but there are many people much smarter and experienced than me who have written solid books on the subject that can be very helpful for the studious. Otherwise there are a ton of classes and free online materials out there, go find what works for you!

For the purpose of addressing the manufacturers comments to FDA, let’s just say that HACCP is a food safety control system that requires not just “the plan” on file, but actual actions and documented controls during production based on that plan. Basically, the company saying “we’ll get one of those” is inadequate even if they were to get a paper copy stored somewhere onsite.

It would be like me asking you to get a job, and you responding that you’ll work on getting a job description to show me. You didn’t really get what I was asking for, and the piece of paper itself isn’t going to cut it.

On sanitation:

our investigator observed the interior surfaces of your shrimp roaster and shrimp grinder… contained red colored shrimp residues. An employee told our investigator the equipment had last been used in October, approximately two months prior to this observation…In your December 26th response, you stated that your employees had thoroughly cleaned the interior and exterior of the roaster of dried red colored shrimp residue. However, your response is not adequate. Your response did not address the cleaning and condition of the shrimp grinder, which was the other piece of equipment colored residues were observed.  Furthermore, you did not provide any corrective action to ensure this problem will not recur.

So a couple things here. First, this is a weird finding in some ways, because in general dirty equipment is dirty equipment, as long as it isn’t being used before getting cleaned it doesn’t pose a food safety risk necessarily in the same way a dirty cereal bowl in your sink isn’t a food safety risk. However, accumulation of food debris on equipment just hanging out in the plant is a source for microbial contamination and a pest attractant, and two months is pretty long to hang onto something covered with bits of shrimp (or spoiled milk residues in the aforementioned cereal bowl). FDA may have also suspected that the equipment was either being used in that condition, or would be used in that condition without cleaning.

The company’s response was inadequate because they didn’t actually say they cleaned each piece of equipment FDA identified as dirty (and should have included pictures as well).

“Honey, please pick Tommy up from basketball practice and Sue from daycare tomorrow”

“Okay, I picked up Sue! Are we done here?”

No, you’re missing something there. The other reason the response was inadequate is that FDA wants companies to demonstrate why this wouldn’t be a finding the next time they visit. Something along the lines of “we created a new equipment inspection program and policy where equipment may not sit idle for more than two days or a weekend without being cleaned of any residues. This is audited by our QA guy and the staff was trained…”. Just answering with “we did this because FDA asked us to” does not give confidence that the same situation won’t just happen when FDA isn’t there.

During our inspection, our investigator observed the hand washing sink located in the processing area lacked running water of suitable temperature for employees to adequately wash their hands, and the water running from this sink was not clear, but yellowish in color. In your December 26th response, you stated that the “water level flow has been cleared so that the water is clear” and your employees were “told to use so that water does not sit and get that yellow coloring.” Your response is not adequate because it does not address correction to the water temperature.

FDA requires warm/hot water for handwashing to be available, and certain standards require the water to turn hot within X seconds. In this facility, hot water was not plumbed to the sink or was on the fritz, and the water coming out was yellow in color, an indicator of pipe corrosion or some other issue.

The firms response was inadequate because they once again didn’t address all the issues. They focused on the yellow coloring by saying the lines just needed to be flushed. I pick up on this as another indicator that handwashing wasn’t actually taking place on this line since the water was stagnant and employees were “told to use” the sink from now on.

But even though the color was spoken for, the company didn’t continue and address the lack of hot water! Either they didn’t read their 483 or were hoping they could let that one slide by. Clearly FDA paid attention to the response and didn’t let it sneak through (good job FDA!).

On December 6, 2016, our investigator observed the wooden shelves in your outside shrimp drying room contained green colored shrimp residues and apparent insect excrement…In your December 26th response, you stated that the outside drying room was cleaned of the green shrimp residues as well as any droppings. However, your response is not adequate because you did not provide any corrective action to ensure this problem will not recur. You must take effective measurements to ensure pests are excluded from your food processing facility.

So residues of shrimp and insect excrement found on shelves inside a drying room. Once again they said “okay, we cleaned it up”, but FDA wants to know they’ll actually keep it clean and, for good measure, keep pests out of their food facility.

As a matter of fact, FDA ended up saying that directly:

 No pests shall be allowed in any area of a food plant. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). However, on December 6, 2016, our investigator observed the following:
a.  Apparent insect excrement, too numerous to count, were observed on a wooden ledge in the upstairs packing and storage area. Directly below the ledge were wooden crates storing unpackaged [products].
b.  Apparent insect excrement, too numerous to count, were observed on wooden shelves and directly on top of a brown-paper packaged bulk raw ingredient product, which were stored on the shelves, in the downstairs processing room.
Additionally, our investigator observed apparent termite damage on the wooden ledge and shelves of your noodle packing and storage areas. During our inspection, you informed our investigator that you were aware of termite issues in the building.

Here we’ve learned a few things. First, we now know that the “excrement” noted in the findings must be termite frass (google away). Second, the manufacturer noted that they use a facility with a known pest problem. Pest infestations are expensive to fix, but if you produce food, it’s not something you get to choose to ignore. FDA responded saying that the corrective actions to move products out of the area and place a tarp over the termite damage “did not address how you will correct the termite problem in your food processing building (emphasis FF&F) and you did not provide the action you had taken to resolve the presence of the numerous insect excrements we observed…”

Next time you are in a fast food restaurant, look around and see if you can spot an insect light trap (ILT). Often they’re decorative like the one in the link, and they work super well at immediately attracting bugs that make it through the door (or other openings). Facilities with preventative pest control will have these in areas where they will be most effective, attracting pests away from sensitive areas. This would have been a good step to try and prevent termite infestation or reinfestation, but at this point the problem is persistent, uncertain, and expensive.

our investigator observed your employee standing on top of a table adjacent to the dough hopper wearing street shoes, and a metal scrapper used to scrape in-process dough from the mixer into the hopper was stored on the table approximately ¼” away from the employee’s street shoes. In your December 26th response, you stated you will move the hopper slightly away from the standing employee shoveling dough and that the scraper will be placed away from the surface of the hopper. We will verify the adequacy of your corrections during our next inspection.

Here the company responded well and addressed the complete finding. First, the hopper was too close to the employee’s shoes (and thus, dust/dirt/fecal material and anything else they may have walked though on the ground), they got it moved away. Second, they moved the product contact tool away from a walking surface where it could have been contaminated. An easy fix, but they did it. FDA noted that they will inspect for it next time, which means they were satisfied. In other cases, FDA might still take issue if this type of tool storage was pervasive, and determine that this kind of response is inadequate. If there were multiple similar situations in the plant, they might not believe people will stop storing tools in these areas just because you corrected it once.

your firm uses wooden materials as direct food contact surfaces in the manufacturing of dried [product]. Our investigator observed in-process products were in direct contact with wooden racks, dowels, and crates, which were in disrepair, worn, and not easily cleanable

wooden-spoonWood + food=nono. While if properly cleaned, dried, and monitored for damage it can be used in the home, wood is still a porous material that can hold water and support the growth of microorganisms, and old wood can break apart and introduce foreign material (splinters) into products. The firm here says they’ll think about replacing these materials with plastic or coating them with plastic, so some of it must be specialty equipment they need to address and not just spatulas and spoons that could be easily and cheaply swapped out. This should be an easy fix for the company, however the storage crates could be a significant expense. Plastic crates aren’t cheap and they may need a lot of them to replace their wood ones.

Considering starting a food company and don’t know what sanitation standard you should meet? Many companies who receive warning letters fail to meet similar requirements enforced at the restaurant level, so check out the food code as a good place to start in an easy-to-follow format. If you think you can meet that standard, check out FDA’s extremely helpful page: How to Start a Food Business.

The information is out there for those who care to seek it.



FDA Warning Letters This Week 2/22/17


The week goes by and new letters come out. Looks like we’ve only got one food letter this week so let’s get into it.

Don’t know what warning letters are? Check out this post for a brief overview of what they are and why FDA sends them out.

WL# 17-PHI-04

CDC Public Health Image library #2287 Credit Elizabeth White (2002)
CDC Public Health Image library #2287 Credit Elizabeth White (2002)

Subject: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes

Ohhhhh it’s an L. mono letter, always interesting. Already we have to pause for some background.

At the end of 2013, CDC and FDA partnered up to stop foodborne outbreaks of Listeria monocytogenes through the utilization of whole genome sequencing (WGS). This technology used to be effectively impossible 30 years ago, and prohibitively expensive and time consuming even 10 years ago.

What this means is that when L. mono is found in foods or a sick person in the hospital, they can sequence it’s entire genome to determine how closely it might be related to other L. mono cultures found in the network. The network consists of genome databases Pulsenet, GenomeTrakr, and The Listeria Initiative, which are jointly managed by CDC, FDA, and local health departments.

Once L. mono has been found and sequenced, in tandem with a traditional epidemiological investigation (interviews, additional sampling of products and environments, illness reporting), the sequence is compared to those in the database to determine if the strain that was found is “closely related” to others and see if there is a link. This is how the listeria found in the Blue Bell products/plant was traced to 10 illnesses that occurred as early in 2010, even when the listeria in the ice cream wasn’t found until 2015. Across several states and 5 years no firm link was established until WGS sequencing revealed the relationship.

There’s some debate about how transparent CDC is about determining when related isolates are causal, or to what level this data should be considered definitive in the absence of confirmed positives in products. However, FDA is going full steam ahead with using WGS as a new enforcement and Epi tool, and CDC has some good data to support the effect on outbreaks it may have had. Whether that’s because manufacturers are more careful in light of the enforcement activities or because the enforcement activities have prevented outbreaks is unclear. But no matter the end result, it’s a win for public health.

The last bit of debate is as to the extent that L. mono can be considered an adulterant. Here in the U.S. we’ve made the determination that if there is any present in the food, it’s adulterated. This is different from several other countries, including Australia/New Zealand and the UK, which allow a non-zero legal limit if L. mono is not expected to be able to grow in the product over it’s shelf life. There’s debate over that as well.

So back to the warning letter:

FDA’s laboratory analysis of fifty environmental swabs collected on September 12, 2016, confirmed that eighteen of the fifty environmental swabs were positive for L. monocytogenes. Of most importance:

Three positive environmental swabs were collected from the following direct food contact surfaces in your cheese processing room during the production of your RTE cheeses:
  • The top of the cheese slicer
  • The cheese slicer string
  • The inside of a plastic crate used to store finished cheese before packaging
–    The remaining fifteen positive environmental swabs were collected from locations adjacent to food contact surfaces and from non-direct food contact surfaces.
–    One positive sample was collected from your RTE feta cheese

They also found a positive in unpasteurized cheese during the facility visit.

This is a pretty solid connection given they found Listeria in the product itself, especially a post-pasteurization product, and that they found it on product contact surfaces where it could continuously inoculate that pasteurized product.  There are other warning letters that claim the products are adulterated when “we found it in the threshold of your entryway to the plant” that don’t always feel solid, but this one is not one of them.

On September 12, 2016, the lift arm and bowl support brackets of the mixer contained areas which appeared to be rusted and contained rough surfaces. In addition, the beater shaft housing area of the mixer, directly above the bowl support brackets, was observed to contain areas which appeared to be rusted and contain food particulates and/or foreign matter.
Food processing tools like my hand mixer have hard to clean areas that can collect food particles like cookie dough, you’ve got to check those areas every time!

Rust happens, and plants have to do regular walkthroughs and replace what needs to be replaced as it ages. But even with the best of intentions, not everything always gets replaced by the time FDA walks through. This makes it a common violation (do you have any rusty or damaged bowls or pots in your cupboard that you plan to replace soon?). But the food particulates are a good find and an indicator of a less-than-robust sanitation standard. Small, hard-to-clean areas around bolts and inside moving parts like the underside of a kitchen-aid (see picture to left) don’t get properly inspected and cleaned unless you have a dedicated program to seek these areas out.

The floors in the processing room and walk-in cooler were observed to be in disrepair, containing areas where the concrete is cracked, rough, and peeling

This one is also common, as mentioned on this site before, cracked/pitted/porous floors are a potential point where environmental pathogens like listeria and salmonella can hide from getting properly cleaned, waiting to jump back out. It’s also a common finding because refinishing or extensive repair of floors is expensive, normally planned on a long-term basis (maybe the slow season so the plant can close or when the contractor has availability), and because in other manufacturing industries it isn’t always a problem (e.g. machine shops).

We have reviewed your written responses to the Form FDA-483, received October 24, 2016, and December 7, 2016…We will ascertain the adequacy of your corrective actions during our next inspection.

Also as discussed here in the past, this is a good sign that FDA knows this company is taking the findings seriously and making real change. Otherwise they would respond with “this is inadequate” and request additional action or proof of change before closing the letter.

Greater than twenty flies landing on the floor, food processing equipment, food processing utensils, and other food contact surfaces and non-food contact surfaces…Three fly catcher tapes containing multiple flies hanging in different areas of the processing room… Dead flies on the window sills near the batch pasteurizer and three bay sink areas.

Well, they had fly catchers, so they know that flies aren’t supposed to just keep flying around, so there’s that. The manufacturer responded that they would purchase a fly zapper and new tapes, but FDA wasn’t satisfied. With pest control, you’re supposed to keep them out of the building and away from your products. So your interventions need to prevent access (find access points, block holes and unscreened windows, create breezeways and air curtains, etc.), and keep them from getting to products with interventions like ILTs.

Your maintenance of the grounds is inadequate to protect against contamination of food, as required by 21 CFR 110.20(a)… Live chickens and pigs coming within approximately one foot of the main door to the production facility and what appeared to be remnants of dead chickens and goats in close proximity to the production facility…Multiple items within approximately twenty feet of the outside perimeter to your production facility which may constitute an attractant, breeding place, and  harborage areas for pests, including, but not limited to, a chicken coop, an abandoned truck, a small four-wheeled loader, wood paneling, vegetation over six feet tall, and other small items which appear to be refuse.

Yep, sounds like a small farm/dairy. I can just picture it, can’t you? Some animals wandering, tall grass, chicken coop, and a couple old trucks and tractors getting overtaken by weeds

Outside of the animal carcasses (obvious pest and disease attractant), this is FDA throwing a little muscle at this farm to clarify that they need to treat it as a food processing facility and not as just a farm. The letter indicates that the company took action to clean up all of these items, however FDA was unsatisfied because they apparently didn’t send them pictures of the cleaned up areas nor discuss how they would keep livestock from hovering around the entrances of the food plant. FDA again noted that they would confirm the changes made were effective at the next inspection, continuing to show that that the inspection itself and initial 483 response must have gone well and the company is doing the right things post-inspection.

Sounds like this company has some work left to do, and that in this case FDA found some tangible and realistic findings of sanitation and facility problems. It helps that the findings were also supported by the L. mono data to really drive home to the company why they should be doing these things. Always nice when cause and effect tie together with GMP’s to drive positive food safety changes home.

FDA Warning Letters this week 2/14/17

I’m back! Check out the About page for more information on the new direction of the blog. Today’s post will be a recurring one. Each week I’ll go through the FDA warning letters recently posted, read through the ones related to food, and offer a summary of any interesting findings and/or findings that we as consumers should or shouldn’t be paying attention to.


First, because this blog is about education and communication, let’s help out those who don’t know what an FDA warning letter is. Per FDA:

When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter.

The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.

This is a good description of what a warning letter is, but when does FDA hand them out?

FDA sees warning letters as a method for encouraging voluntary action to correct problems they found in investigations, after-market product testing and label review, plant inspections, and to increase the pressure on companies that aren’t responding to form 483 findings (inspection violations).

In FDA-speak this means that they’re avoiding forced action that would be supported by a judge or federal officer, such as injunctions or seizing products and facilities. However as far as any reputable food company is concerned, it’s really being voluntold. After all, companies that do not respond to warning letters are almost guaranteed to subsequently receive actual enforcement actions, and because warning letters are public, if a company is in the public space in any large way (e.g. a recognizable brand) getting your warning letter closed is an additional public step to regaining consumer trust.

This is just a brief overview, for more information on FDA decision-making in regards to why a warning letter might be issued you can read their procedures. It also contains a lot of information about “prior notice” and other legal requirements the warning letter satisfies.

FDA warning letters this week

Now let’s get to the goods! In these posts I’ll be using the warning letter numbers to identify specific letters and avoid typing company names simply for the sake of making it about the information in the letter and not the addressee. If you’re curious about which companies received the letters, you can check them out yourself or google the warning letter number, that should get you there.

I picked a doozy of a week to start doing this, there are some extensive and complex letters here, I’ll keep my comments “brief”, but check out the letters for yourself to read the full scope of violations.

WL# 14-17

Subject: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

Seafood shows up a lot in warning letters for HACCP violations. Companies and produce Juice and Seafood have specific critical control points and HACCP plans spelled out in the regulations. Oftentimes small companies or importers who have never been inspected, or were never aware of what their requirements were, violate or do not put these programs in place. Because this is considered an imminent threat to food safety, FDA almost always issues a warning letter. Most of what you see are companies that just straight up don’t have the programs in place, rather than specific violations. This warning letter is actually a follow up to a previous one, where FDA reviewed the corrective actions of the company and determined that they weren’t enough.

We received your written response dated January 10, 2017 which included Product Specifications and Importer Written Verification Procedures…However, your product specifications failed to identify the hazards that are specific to the product.

Off the top of my head, I would guess that the person who wrote the specifications in response to the letter has not had formal HACCP training and didn’t understand how to carry out an actual hazard analysis, or where the information could be found in the CFR. Ultimately this warning letter represents a failure of a company both to follow prescribed regulations and understand the value of HACCP and Preventative Food Safety.

If you are interested in HACCP, I’ll probably cover many basic principles throughout this blog, but there are many people much smarter and experienced than me who have written solid books on the subject that can be very helpful for the studious. Otherwise there are a ton of classes and free online materials out there, go find what works for you!

WL# 2017-NOL-03

Subject: CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

I love seeing this subject on warning letters, because it usually means we get some insight into how FDA enforces current good manufacturing practices (cGMP or GMP). Other times, we just get to hear about gross conditions within a plant. It’s really a mixed bag of findings, but they’re usually interesting in one way or another.

The first set of findings for this letter concerned inspectors finding flies, bugs, and rodent excreta pellets (REP’s, and one of my favorite acronyms ever) in the bakery. Thankfully, the REP’s were found underneath a mop sink in the corner, and not somewhere closer to food (some warning letters are much more nauseating with respect to where they find these things). The flies were found throughout the facility, both on products and equipment as flies in your home would. Not a good start. I imagine this facility has either no pest control program or doesn’t use a professional. Either way the presence of the flies indicates that their presence was “normal” and that this facility needs culture change. Further demonstrated by FDA noting that they found pests in inspections for two previous years (clearly no lesson was learned).

Next time you are in a fast food restaurant, look around and see if you can spot an insect light trap (ILT). Often they’re decorative like the one in the link, and they work super well at immediately attracting bugs that make it through the door (or other openings). Facilities with preventative pest control will have these in areas where they will be most effective, attracting pests away from sensitive areas.

The second set of findings concerned handwashing practices. These weren’t the worst ones you see. The ones that are immediately concerning are when FDA notes things like employees using the restroom or dirty surfaces like pest traps and mop buckets, then going back to touching products. In this plant the inspector took note every time an employee left the area or touched non-food surfaces and returned to food without stopping to wash their hands. This is wrong, and the company again has a culture issue, but remember that doctors only follow proper handwashing 40% percent of the time as well. So while it’s the wrong behavior for handling food, it’s far from abnormal and a constant struggle in all settings.

Additional findings concerned sanitation and handling of food contact surfaces. And…well, these some things that directly inoculate your products with bacteria.

packaging material…was observed in direct contact with the floor soiled with food debris

The baking sheet pans came into direct contact with a trash can during scraping.  The sheet pans were not cleaned or sanitized after contact with the trash can before unbaked 9” pie shells were placed onto the sheet pans.

observations [of accumulated food debris on equipment] were noted after the previous day’s production run and prior to production start-up on each of the aforementioned dates.  Production commenced without removal of the observed food debris.

The rest of the findings show pretty severe deficiencies with the way the company conducts itself, handles products and materials in the facilities (including storing secondary packaging in the employee bathroom…) and in general fails to maintain a sanitary facility for food production. Honestly this warning letter is so chock full of obvious contamination issues it’s frustrating that FDA hasn’t taken action sooner. After all, more than half of the observations are followed by the note:

This is a repeat observation from the 9/20/2010 FDA inspection.

This is where I get frustrated as a member of the industry, a taxpayer, and a consumer. According to FDA’s database of inspections, they’ve visited this facility on the following dates: 4/14/09, 9/23/10, and 6/10/11. According to the database, that’s the last time they’ve been there until the inspection noted in this warning letter (10/18/16). They were also never issued a warning letter for those inspections in 2011. Either they decided the State of TN was in charge of following up at the state level, they contracted FDA inspections through the state of TN in the intervening 5 years, or no one inspected this facility for 5 years after finding all these problems in 2011.

We won’t ever know, but regardless of what happened in the intervening 5 years, we should be grateful FDA is taking action now, and found the facilities response to a 483 issued at the inspection:

…[we] have determined your response is inadequate.  You have not provided evidence such as photographs, receipts, and/or training documentation to show you have corrected any of the violations observed.

Here’s hoping some pretty good evidence was provided in 2011.

WL# 2017-NOL-05

Subject: Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

This letter is for similar violations as the first one we discussed for failing to adhere to seafood HACCP regulations. However this producer actually has a properly constructed hazard analysis and HACCP plan, but failed to properly execute it.

The firm had a cook step for crab that included a time/temperature combination to ensure that any pathogens would be killed. By reviewing the companies records, FDA observed that 9 different times employees had ended the cooks too early but no notes or corrections were made. This is concerning because it means that product may have been released undercooked, and employees running the equipment didn’t have the training necessary to follow the cook instructions, or understand why ending it prematurely was unacceptable.

The letter indicates that the company and FDA have been working through this issue, FDA indicates that the response has been inadequate for lack of evidence. Protip: if you tell FDA “we modified our HACCP plan to your recommendations”, you have to send them the modified HACCP plan. It’s amazing how many follow-up letters have to tell companies this or similar.

This facility also had sanitation issues, not as severe as the bakery above, but running on dirty equipment undermines any HACCP plan or cooking step you do.

You are not monitoring the cleanliness of food contact surfaces as evidenced by previously cooked crab parts from operations on the previous day and after cleaning operations were observed on the metal conveyor were observed to come into direct contact with newly cooked crabs on the conveyor belt.

Protip: if there’s still pieces of the food from the last time you used it, it isn’t clean.

Among the sanitation violations however, FDA notes that the correction actions the company informed them of are acceptable enough that they will verify at next inspection, rather than simply reply that “response was not adequate”, which is a good sign that FDA has confidence the company will get it together and can be trusted to keep improving without direct supervision. From the letter I get the impression that the company had problems, but didn’t have the longstanding culture and facility issues we saw manifesting in the bakery discussed earlier. After all, they couldn’t demonstrate that the low concentration of chlorine in their sanitizing stations was such a pervasive problem without also noting that employees were actually using the sanitizer stations frequently.

WL# CMS Case # 516352

Subject: Acidified Foods/Prepared Packed or Held Under Insanitary Conditions

Acidified foods are foods in hermetically sealed (airtight) containers that could support the growth of microorganisms (high water activity), but are modified with acidic ingredients to bring their final pH to 4.6 or below. FDA strictly regulates these foods because they have the potential to support the growth of Clostridium botulinum which causes botulism, a truly terrifying disease.

Because of these strict regulations, we often see warning letters related to not following HACCP/regulatory requirements for acidified or low-acid foods, very similarly to those we see for juice and seafood. This producer had a lot of issues that come down to them not following these regulations and controlling the process of production, leading FDA to crack down because they present a risk of growing Clostridium species in their products. Check out the letter for those specifics.

In addition to the acidified foods violations, the firm had some interesting violations connected to glove use. Nitrile gloves are often associated with food safety, but they aren’t magic. A clean hand is better than a dirty glove, and this firm demonstrated this with a few well observed glove observations:

an employee…had a tear on the glove worn on his right hand. The tear extended from the palm to the backside on the hand across the area between the thumb and fore finger.

an employee…was observed picking up a lid which had fallen to the floor and placing it in a sink. The employee did not wash or sanitize his gloves before returning to capping the filled jars of product

The only food safety “magic” that gloves provide is that they can be changed. A glove change and sanitize can save time and provide convenience to employees who do things like pick up objects they dropped on the floor or open doors when they don’t have to walk away to a handwashing sink. Provided that the gloves themselves are also in a convenient nearby location.

And when it comes to enforcing food safety behaviors, convenience=compliance.