As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Mena Food Group LLC
Fort Lauderdale, FL
The U.S. Food and Drug Administration has issued a warning letter to Mena Food Group LLC, citing numerous violations of federal food safety and labeling regulations at its Fort Lauderdale facility. The letter, dated Aug. 8, 2024, follows an inspection conducted from Oct. 30, 2023, to Nov. 20, 2023, during which FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (CGMP & PC) rule under Title 21, Code of Federal Regulations, Part 117.
The FDA also issued a Form 483, Inspectional Observations, at the conclusion of the inspection, but Mena Food Group has yet to provide a written response addressing the observations.
Violations detailed in the letter:
The FDA identified several critical issues at the facility, including:
1. Failure to address known hazards:
The company did not adequately evaluate or address foreseeable hazards requiring preventive controls, such as:
Environmental pathogens: The facility failed to implement controls for pathogens like Salmonella and Listeria monocytogenes in its ready-to-eat (RTE) products during post-baking stages.
Mycotoxins: Mena Food Group did not establish a supply-chain program to monitor ingredients, such as wheat flour, associated with mycotoxins like deoxynivalenol (DON).
Undeclared allergens: The company’s failure to label allergens, including wheat, soy, sesame, and tree nuts, was deemed hazardous.
2. Allergen cross-contact and labeling deficiencies:
Investigators found the company lacked sufficient monitoring, corrective action, and verification procedures to prevent allergen cross-contact during production. Products such as challah burger buns and hoagie rolls were found without proper allergen declarations.
3. Hygiene violations:
FDA inspectors observed several hygiene lapses, including employees failing to wash hands after exiting the facility and re-entering production areas. Other violations included open beverage containers near food preparation areas and direct hand-arm contact with RTE frosting during production.
4. Facility maintenance issues:
The facility was cited for unsanitary conditions, such as apparent mold-like substances on light fixtures and ceiling tiles in production areas and heavily soiled fans blowing onto uncovered RTE products.
5. Misbranding violations:
Several RTE products, including cupcakes, buns, and cakes, were misbranded for failing to declare allergens, list common or usual ingredient names, and provide accurate statements of net quantity or manufacturer information.
The full warning letter can be viewed here.
Calavo Growers Inc.
Keaau, HA
The U.S. Food and Drug Administration has issued a warning letter to Calavo Growers Inc., highlighting violations of the Produce Safety Regulation at one of its contracted papaya farms. The letter, dated Oct. 25, 2024, stems from a domestic investigation conducted on April 16, 2024, at Calavo’s papaya packing facility, followed by an inspection of a contracted farm from April 20-22, 2024.
The FDA issued a Form FDA 4056, Produce Farm Inspection Observations, to the contracted farm after identifying significant violations.
Violations detailed in the letter:
The FDA found that the farm did not provide adequate, readily accessible toilet facilities for workers in growing areas during harvesting activities. Specifically, workers were forced to urinate in bushes near the fields because the sole toilet facility was located 0.30 miles from the harvesting site. The violation was previously observed during a 2023 inspection, making it a repeat offense.
Calavo representatives acknowledged the violations and verbally committed to relocating toilet facilities closer to growing areas and ordering additional composting toilets to cover all contracted farms. The FDA emphasized that Calavo Growers bears responsibility for ensuring compliance with federal safety standards, even when contracting with independent farms.
The full warning letter can be viewed here.
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