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.