July 14, 2024

The FDA’s “Best” Worst Warning Letters of 2022

When the FDA discovers that a company has significantly violated federal regulations, the agency issues a warning letter. These letters enumerate some of the key violations and instruct the offender to devise and execute a plan to correct them within a designated timeline. All of these letters deal with serious food safety violations – filth, pests, bacteria, but some really stand out. Here are some of the notable warning letters the U.S. Food and Drug Administration (FDA) sent in 2022.

“A History of Infestation”

Dollar Tree Inc.

This letter, sent November 8, 2022, pertains to an FDA inspection that took place January 11 – February 11, 2022, at Family Dollar Distribution Inc., located at 1800 Family Dollar Parkway, West Memphis, AR. At that time, the facility stored and distributed human foods and dietary supplements; animal foods; cosmetics; over-the-counter drugs, and devices.

The letter acknowledges that on February 18, 2022, Dollar Tree issued a recall for products that had been stored at the facility and shipped to 404 stores in six states due to the presence of rodents and rodent activity at the facility.

The recall doesn’t say what an FDA consumer advisory issued the same day summed up this way: “Conditions observed during the inspection included live rodents, dead rodents in various states of decay, rodent feces and urine, evidence of gnawing, nesting and rodent odors throughout the facility, dead birds and bird droppings, and products stored in conditions that did not protect against contamination. More than 1,100 dead rodents were recovered from the facility following a fumigation at the facility in January 2022. Additionally, a review of the company’s internal records also indicated the collection of more than 2,300 rodents between Mar. 29 and Sep. 17, 2021, demonstrating a history of infestation.” The warning letter goes into more detail.  Some specific examples:

  • Rat and bird carcasses were found throughout the facility.
  • Groups of rats scurrying across the floor or climbing pallets.
  • Significant gnawings, rat poop, and a strong odor of rodent urine and poop on a pallet containing cases of mixed nuts.  Multiple bags had been gnawed open, and the product was spilling out.
  • Rat poop and gnawings on a pallet of flour. “While investigators unstacked the pallet, two mice exited from gnawed-open product bags stacked on the bottom layer of the pallet and ran west under the north end of the aisle.”
  • Rat poop, gnawings, and nesting material on a pallet containing cardboard cases of Chicken Flavor Rice & Pasta Blend product.
  •  Spilled breakfast cereal, Chicken Flavor Rice & Pasta Blend product, flour, popcorn, and sunflower seeds mixed with rat poop and urine.
  • Bird droppings on chocolate protein shakes and Vitamin C supplements.
  • Rat poop and rat hair on top of a pallet of Vitamin C  supplements.
  • “A strong foul odor/stench of dead and decaying rodents, rodent pellets, and evidence of rodents nesting in and around the Inventory Control Center (ICC) and the breakroom.”  Employee complaints about the smell prompted the General Manager to close the rooms in October 2021. “Inspectors observed that the ICC was cleared out and closed off, and a putrid odor continued to permeate the room. The breakroom above the ICC was closed and rodent nesting materials were in front of the entrance.”
  • Piles of trash extending approximately 2 feet out from the walls of the facility.
  • Piles of food near or spilling out of large open-top dumpsters.
  • Gnawings and rat poop on bags of dog food.
  • Rat poop and hair on pregnancy tests.

An FDA review of internal emails revealed that the facility had been getting complaints about evidence of rodent activity from stores receiving shipments as far back as December 8, 2020. The FDA’s findings prompted Arkansas Attorney General Leslie Rutledge, to file a lawsuit against the company in April 2022 citing its reckless, willful, intentionally deceptive practice of distributing and selling potentially hazardous, adulterated, or contaminated products. The company permanently closed the facility at the end of June. FDA warning letters

“Resident Pathogen”

Bakkavor Foods USA Inc.

On August 8, 2022, the FDA sent Bakkavor Foods USA Inc. a warning letter about its findings from an inspection of its manufacturing facility located at 2700 Westinghouse Blvd, Charlotte, NC that took place on February 7-11, 15, and 23, 2022.

Bakkavor makes ready-to-eat (RTE) dips, soups, salad bases, burritos, entrée style meals, and seafood products. After the inspection, the company sent four responses to the FDA (one each month from March to June) describing the actions it had taken to correct the problems the FDA had found. But those efforts came up short, prompting the agency to outline its “continuing concerns” in a warning letter.

Topping 5,600 words, the letter is one of the longest reviewed by Food Poisoning Bulletin. It ticks off a list of offenses that are fairly common in these letters -gunky equipment, condensate dripping from the ceiling, pooled water on the floor, and lack of a hazard control plan. It details some serious temperature abuse issues – the finished-product-cooler continuous temperature monitoring device had been disconnected, and recorded temperatures that were frequently out of the proper range. But the biggest problem can be summed up in two words “resident pathogen.”

The section entitled “Listeria monocytogenes in your facility” begins this way,FDA’s environmental findings indicate that you have a resident strain of L. monocytogenes in your facility, as well as transient strains.” 

On February 8, 2022, the FDA collected 110 environmental samples and tests showed 14 were positive for Listeria monocytogenes which can cause serious illness and death. And it wasn’t the first time. In 2019 and 2016, the North Carolina Department of Agriculture & Consumer Services (NCDA) collected samples from non-food-contact surfaces, including the floors and drains that were positive for Listeria monocytogenes. And in 2009 and 2008, the FDA collected swabs from non-food-contact surfaces, including the floors and drains that were positive for Listeria monocytogenes.

Using whole genome sequencing, health officials were able to identify the genetic “fingerprint” of the strains. This information revealed that a Listeria strain collected in 2o22 was also collected in 2019 and 2009. “The presence of the same strain of L. monocytogenes over multiple years is indicative of a resident pathogen in your facility,” the letter states.

A resident pathogen is a clear indicator that cleaning and sanitizing procedures are inadequate. And in the four responses to the February inspection Bakkavor made, the company never demonstrated that it had located and eradicated the problem areas or provided supporting documentation of corrective measures, the FDA said. These issues will all be checked at a follow-up inspection.

Radio Silence after a Deadly Outbreak

Big Olaf Creamery LLC

In 2022, Big Olaf ice cream was linked to a Listeria outbreak that caused 28 illnesses, one death, and one miscarriage, according to the Centers for Disease Control and Prevention (CDC). The illnesses occurred over a 20-month period. Twenty-seven people were hospitalized.

On July 1, when Big Olaf was presented with information that epidemiological evidence had tied the company’s ice cream to a deadly Listeria outbreak, the company declined to issue a recall.  A spokesperson for the company issued a statement that called the epidemiological information “speculative” and claimed that the company was being unfairly “targeted.”

On July 13,  the state of Florida shut down production of all Big Olaf ice cream after nine environmental samples collected from the creamery’s facility on Cattleman Road in Sarasota, Florida tested positive for Listeria. Two days later, a 10th environmental sample and samples from 16 ice cream flavors also turned up positive. Then Big Olaf issued a recall.

Genetic tests showed that the outbreak strain of Listeria was found in ice cream samples and at the plant where the ice cream was made.

The FDA conducted an inspection at Big Olaf’s facility, located at 2001 Cattlemen Rd., Sarasota, FL, from July 19 to September 01, 2022. The warning letter, dated December 9, 2022, lists the violations such as lack of a food safety plan, a hazard analysis, preventative control measures, or corrective action procedures. And it states that the company had yet responded to the inspection report issued at the end of the inspection.

The last state inspection record is dated October 10, 2022, according to the Florida Department of Agriculture and Consumer Services website. It states, “the Stop-Use Order/ Stop-Sale Order issued 7/13/22 (processing room and equipment) and 8/5/22 (warehouse) remain in place.”    

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