In response to the infant formula supply crisis in 2022 and the deadly infections that led to it, the FDA has updated its infant formula compliance program.
An outbreak of Cronobacter infections in five infants, two of whom died, started in the fall of 2021 and stretched into early 2022. Abbott Nutrition initiated a recall of Similac infant formula powder and other brands in February 2022. The recall led to a nationwide shortage and left parents driving for hours in search of formula for their babies.
During its investigation, the Food and Drug Administration found Cronobacter contamination in Abbott’s production plant in Sturgis, MI. The agency also discovered that the company had tested product and received positive outcomes for Cronobacter, which Abbott had not reported to the FDA.
In May 2022, after grueling congressional hearings, FDA officials launched an internal investigation that included review of issues raised by a whistleblower complaint. The new compliance program is in response to that investigation. The program covers FDA investigators, laboratory analysts, and compliance officers.
“The infant formula compliance program is designed to comprehensively outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities to help ensure that infant formula products in the U.S. food supply are safe and nutritious,” according to a statement from FDA.
“The FDA has now published its updated compliance program, which builds on lessons learned over the last several years to elaborate on our approaches for inspections, sampling, laboratory analysis, and imported infant formula products.”
Going forward, to be in compliance entities must follow updated instructions for annual environmental sampling at powdered infant formula production facilities. Those sampling tests must include Cronobacter and Salmonella. If testing shows either of the pathogens the FDA must be notified. The agency also must be notified if testing shows nutrients that are above or below required levels per the FDA’s infant formula regulation.
The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program at the Food and Drug Administration.
Additional background on the risks associated with Salmonella and Cronobacter in infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, is included in the updated compliance program.
In addition, it further elaborates on new infant formula related requirements that were included in the Food and Drug Omnibus Reform Act of 2022.
Greenhead Lobster Products LLC‘s (Greenhead) ready-to-eat (RTE) seafood processing facility in Bucksport, Maine, suffers from a chronic environmental contamination with Listeria monocytogenes, according to information extracted from US Food and Drug Administration’s website.
The persistent presence of the pathogen in the production environment has been known to the company and the FDA for at least the last two years.
First inspection: 2020
The FDA first visited the Bucksport facility in December 2020, issuing a list of adverse Inspectional Observations (FDA Form 483) upon completion of the inspection.
According to the agency’s inspection citations database, the FDA investigators cited four violations, including:
Failure to implement the monitoring procedures listed in the company’s HACCP plan;
Failure of the HACCP plan to list the food safety hazards that are reasonably likely to occur;
Failure to monitor the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including prevention of cross-contamination from insanitary objects; and
A corrective action plan not in accordance with regulatory requirements to ensure that a potentially hazardous product is not entered into commerce.
Second inspection: 2021
After giving Greenhead a grace period of several months to bring its food safety programs into compliance, the FDA performed a follow-up inspection in September-October 2021.
During the 2021 inspection, FDA investigators conducted extensive environmental sampling of the facilities production areas, including food-contact surfaces, and found Listeria monocytogenes in a floor drain.
Upon reviewing the company’s environmental monitoring records, the agency noted the presence of thirteen (13) recurring L. monocytogenes positive swabs between May 2021 and August 2021 from the RTE (ready-to-eat) processing room, including eleven (11) swabs collected from food-contact surfaces.
Although the company’s records indicated that the relevant areas were cleaned and sanitized following each positive finding, Greenhead did not conduct any root cause analysis to establish and eliminate the source or sources of the contamination.
Recall #1
On October 2, 2021, while the FDA inspection was still in progress, Greenhead initiated a voluntary product recall, encompassing 5,749 lbs. of frozen cooked lobster meat. The recall cited a “…potential for contamination … noted after a routine sampling program by the company revealed the presence of Listeria monocytogenes.”
Once again, the FDA issued a Form 483 upon completion of the inspection, this time classifying the situation as “Official Action Indicated.”
Warning Letter
On January 24, 2022, after exchanges of communcations regarding the company’s plans for correcting the various deviations, the FDA issued a formal Warning Letter, giving Greenhead a deadline to respond to all outstanding issues.
The Warning Letter reiterated the list of observations included in the Form 483, providing examples to support each item. These included:
Ongoing serious concerns with the company’s HACCP plan
Ongoing concerns about the company’s inability to control Listeria monocytogenes in the production environment
Significant deviations from requirements of the Seafood HACCP plan
Insufficient monitoring of sanitation conditions and practices during processing
Inadequate control of the hazard of Clostridium botulinum in high pressure processed (HPP) lobster products.
Third inspection: 2022
In July 2022, the FDA returned to Bucksport yet again to follow up on Greenhead’s response to the Warning Letter.
And yet again, the company’s performance was found wanting.
The Form 483 issued upon completion of the July 2022 inspection listed four main concerns:
Greenhead’s HACCP plan did not list the food safety hazards that were reasonably likely to occur
The HACCP plan listed a critical limit that failed to ensure control of one or more hazards
The company did not take corrective action to prevent potentially hazardous product from entering into commerce, and did not correct the cause of the deviation
The company was not monitoring sanitation conditions and practices with sufficient frequency to ensure compliance with current Good Manufacturing Practices.
At the close of inspection, company management agreed to make the necessary corrections and the FDA classified the results of the inspection as “Voluntary Action Indicated.”
Fourth inspection: 2023?
Recall #2
Just over one year later, on October 20, 2023, Greenhead announced another voluntary product recall, this time encompassing “…all frozen and refrigerated cooked lobster meat products produced from May 9, 2023, through October 19, 2023.”
The reason given for the recall was the presence of Listeria monocytogenes in the production environment.
Although the environment was contaminated, the pathogen was not found in finished products, and there were no illnesses associated with the recalled products.
The recall encompassed eleven ready-to-eat, refrigerated or frozen lobster products. Please refer to the recall notice for a detailed list of affected products.
The recall notice made no reference to the FDA. Nor has the FDA posted information on a 2023 inspection in its Inspection Citations database.
Nevertheless, past experience suggests that another follow-up inspection is either still in progress or has been completed recently.
What next for Greenhead Lobster Products?
Although constituted as a regulatory agency, the FDA has a history and a philosophy of giving the food companies it regulates multiple chances to self-correct.
Sometimes, this works well. Other times, it does not.
Greenhead has now been inspected on at least three (and possibly four) separate occasions, and its HACCP and sanitation programs were found wanting each time.
The FDA has the power to demand compliance (via a Warning Letter), to mandate recalls (when circumstances demand), and even to shut down a facility by suspending its registration.
Except for the issuance of a Warning Letter, the agency rarely makes use of these regulatory powers.
Will Greenhead prove to be one of those rare occasions, or will the FDA sit on its hands until one or more illnesses are linked to the company’s products?
Stay tuned.
“Reads like a true crime novel” – Food Safety News
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The US Food and Drug Administration (FDA) is updating its previously issued advisory concerning Darwin’s Natural Pet Products after finding Salmonella in yet another sample of the company’s raw pet food.
The latest Salmonella finding concerns the following product:
Darwin’s Natural Pet Products Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats, Lot 9802, manufactured on Jul 7, 2023.
Previously, the FDA warned consumers about Salmonella contamination in the following products:
Darwin’s Natural Pet Products Natural Selections Chicken Recipe with Organic Vegetables for Dogs, Lot 9774, manufactured on Jun 13, 2023.
Darwin’s Natural Pet Products Natural Selections Chicken Recipe for Cats, Lot 9795, manufactured on Jun 28, 2023.
Darwin’s Natural Pet Products Natural Selections Chicken Recipe for Cats, Lot 9830, manufactured on Jul 19, 2023.
As of the updated (October 12, 2023) advisory, the company has declined to recall any of the Salmonella-contaminated products, which were manufactured by Arrow Reliance Inc., doing business as Darwin’s Natural Pet Products, and sold online.
On February 16, 2023, the FDA issued a Warning Letter to Gary Tashjian, Owner of Arrow Reliance Inc., citing evidence of Salmonella contamination in the company’s finished products, the use of a non-permitted food additive (peroxyacetic acid) as a pathogen mitigation step, and Tashjian’s refusal to comply with federal requirements that it register with the FDA as a food facility.
What consumers should do
If you have any of the Darwin’s Natural Pet Products Natural Selections cat or dog foods listed above, stop feeding it to your pets and throw it away in a secure container where other animals, including wildlife, cannot access it.
Consumers who have had this product in their homes should clean refrigerators/freezers where the product was stored and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, litter boxes, toys, floors, and any other surfaces that the food or pet may have had contact with. Clean up the pet’s feces in places where people or other animals may become exposed. Consumers should thoroughly wash their hands after handling the product or cleaning up potentially contaminated items and surfaces.
TOXIC
From Factory To Food Bowl PET FOOD IS A RISKY BUSINESS
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Enjoy the slideshow as you listen to a sample of TOXIC, narrated by the author.
“A complete and compelling account of the hidden and not-so-hidden ways the food we give our beloved pets can be contaminated.” – JoNel Aleccia, Health Reporter, Food & Nutrition, The Associated Press.
