FDAWarningcolor_406x250Following inspections, the Food and Drug Administration issued warning letters, recently made public, to a seafood processing facility in Nicaragua, a juice processing facility in Iowa and a tofu production facility in Washington D.C.

Companies have 15 working days to respond to FDA warning letters. None of the three companies listed below have received close-out notices on the warnings from FDA as of Feb. 5.

Compania Pesquera Charly SA, dba Copescharly SA, Nicaragua
In a Jan. 5 warning letter to Carlos Goff Amador, general manager, the FDA cited “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation in the U.S. federal code. The violations caused the company’s sea cucumber products to be “adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”

The problems were discovered during an inspection on June 9-10, 2016, according to the warning letter. On Sept. 3, 2016, the company notified FDA of changes made to address the problems, but the changes were not adequate, according to the warning letter.

“… your firm’s revised HACCP plan for ‘Dry Salted Sea Cucumber without Innards’ does not list a critical limit for water activity (Aw) to control pathogen growth and potential toxin formation in your shelf stable products,” the FDA warning letter states. “Products that are dried and/or salted and intended to be held at ambient room temperature — i.e., not intended to be held under refrigeration — need to achieve a final Aw of 0.85 or below to ensure the safety of the products.

The Nicaraguan seafood company also failed to implement adequate pathogen monitoring programs. The programs do not include proper temperatures and are not frequent enough to be effective, according to the warning letter. The FDA found specific problems with the company’s program to control toxins in its frozen whole sea cucumber product.

“This corrective action will not control the hazard of preformed S. aureus toxin, which is heat stable and will not be controlled during your boiling or drying process. FDA recommends rejecting the lot or diverting it for non-food use,” the warning letter states.

Fox Ridge Farm Inc. dba Wilson’s Orchard, Solon, IA 
In a Jan. 20 warning letter to Paul L. Rasch, president and co-owner, the FDA cited “serious violations” of the juice HACCP regulation in the federal code. The violations rendered the company’s apple cider products adulterated as defined by federal law.

FDA WarningThe violations were discovered during an inspection on Oct. 18-19, 2016, and the company had not responded to FDA regarding the inspection findings as of the writing of the Jan. 20 warning letter.

“… your firm does not have a HACCP plan for your apple cider product to control the food hazards of pathogens, patulin, and metal fragments,” the warning letter states.

Specific problems cited in the warning letter include:

  • Rust and corrosion on the cider press line used to make sweet cider were found on surfaces that come into contact with apples;
  • There were no directions for proper use of the caustic cleaner being used on apple cider processing equipment;
  • Two dock doors and a door next to the cider press line were left open during production and inspectors observed flying insects and apparent mosquitos too numerous to count; and
  • The company’s pest service does not include insect control.

Wilson’s Orchard also did not have required sanitation control records as required by federal law.

“your firm did not maintain sanitation control records for the following areas of sanitation: monitoring the safety of the water that comes into contact with food or food contact surfaces; the prevention of cross-contamination from insanitary objects; the maintenance of hand washing, hand sanitizing, and toilet facilities; the protection of food, food packaging material, and food contact surfaces from adulteration with contaminants; the proper labeling, storage, and use of toxic compounds; the control of employee health conditions that could result in microbiological contamination of the food, food packaging materials, and food contact surfaces; and the exclusion of pests from the food plant,” according to the warning letter.

Nam & Nam Inc. t/a Sam Sung Tofu, Washington D.C.
In a Jan. 24 warning letter to Ray Wu, owner, the FDA cited “significant violations” of the Current Good Manufacturing Practices (CGMP) for foods. The violations rendered the company’s tofu products adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may been rendered injurious to health. Further, FDA reviewed product labeling for the tofu products and found significant violations of FDA’s food labeling regulation.

The problems were discovered during an inspection from July 21 through Aug. 10, 2016, and included a live rat in the production area and “and apparent rodent excreta pellets too numerous to count” in the storage area.

FDA inspectors also found that utensils and production equipment was not being sanitized and that the cleaner Pyrene US 1021 was used on food contact surfaces despite the fact that its warnings include “keep away from food and drink.”

The tofu company also was found to be storing product at 49.5 degrees and not monitoring the temperature of the walk-in refrigerator. The temperature on a steam vat was also broken and clean water was not available.

“Your firm’s plumbing constitutes a source of contamination to food, water supplies, equipment and utensils,” according to the warning letter.

The misbranding problems involving improper labeling included failing to include all ingredients, failure to provide required information in English, failure to state the product requires refrigeration, and improper nutritional claims regarding cholesterol and protein.

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