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. The FDA frequently redacts parts of warning letters posted for public view.
D&C Seafood Inc.
Venice, LA
A food firm in Louisiana is on notice from the FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
In a Sept. 15, 2021, warning letter the FDA described inspections on July 26, 2021, at D&C Seafood Inc.’s seafood processing facility in Venice, LA.
The FDA’s inspection revealed that the firm’s king mackerel, wahoo, barracuda, and cobia are adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Some of the cited violations:
The firm does not have a HACCP plan for:
1) king mackerel and wahoo to control the food safety hazards of histamine formation;
2) king mackerel and barracuda to control the hazard of ciguatera toxin; and
3) king mackerel, wahoo, barracuda, and cobia to control the hazard of undeclared allergens.
The full warning letter can be viewed here.
OFP Ingredients LLC
Washington, MO
A food firm in Missouri on notice from the FDA after an inspection and environmental samples found the presence of Salmonella Cubana in its facility.
In a Dec. 7, 2021, warning letter, the FDA described inspection of OFP Ingredients LLC tolling operation for dry milk powder processing located in Oconomowoc, WI. The inspections took place on May 26-27, June 8-9, 14-15, 17, 24, and July 19, 23, 2021.
The FDA’s inspection revealed that the firm was not in compliance with Foreign Supplier Verification Program (FSVP) regulations and resulted in the issuance of an FDA Form 483.
Some of the cited violations:
- The firm did not identify and implement preventive controls adequate to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by their facility will not be adulterated.
The firm’s facility processes agglomerated milk powders that are sold for further blending into beverages or for further packaging, and are considered ready-to-eat (RTE) because they are consumed without further processing to significantly minimize biological hazards. Their hazard analysis identified environmental pathogens as a hazard requiring a preventive control at the (redacted) step (redacted) and the filling/packaging step (after agglomeration), where RTE powder is exposed to the environment. The firm identified sanitation preventive controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of Salmonella Cubana in their facility, they did not implement sanitation controls adequate to ensure that their facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen of Salmonella.
FDA laboratory analysis confirmed 10 of 174 environmental swabs collected were positive for Salmonella Cubana. Of these positive findings, three positive swabs were collected from the (redacted) room, a room that they consider a primary pathogen control area where products are exposed to the environment and include the following locations: a crack in the wall and floor junction adjacent to (redacted); the floor and stair junction of the mezzanine level which employees climb to access ribbon blenders; and the floor drain cover adjacent to the mezzanine stairs. Additionally, three positive swabs were collected from the agglomeration room, including the equipment framework under Line (redacted).
These findings demonstrate that the firm’s sanitation procedures have been inadequate to significantly minimize or prevent Salmonella in their facility, according to the FDA warning letter.
In the FDA’s reviewing of the facility’s environmental monitoring program, FDA noted that they have repeatedly found Salmonella through their own testing. In response, they generally have performed vector swabbing, recleaning/resanitizing, and reswabbing. However, it appears that their corrective actions have not been adequate to address their findings and the hazard of Salmonella.
The full warning letter can be viewed here.
Molino Enterprises One Inc.
Bronx, NY
An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Jan. 7 warning letter, the FDA described an Aug. 10 through Sept. 14, 2021, Foreign Supplier Verification Program (FSVP) inspection of Molino Enterprises One Inc. in Bronx, NY.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- whole wheat breadsticks, (redacted);
- (redacted) imported from their foreign supplier; and
- (redacted) located in the (redacted).
The full warning letter can be viewed here.
VHRK Food Inc.
Elk Grove Village, IL
An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Dec. 8, 2021, warning letter, the FDA described a Jan. 21 through Feb. 16, 2021, Foreign Supplier Verification Program (FSVP) inspection of VHRK Food Inc. in Elk Grove Village, IL.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods imported from (redacted):
- Dry dates powder;
- Brown Chori (peas);
- Black pepper; and
- Sun dried gooseberries.
The full warning letter can be viewed here.
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