In its most recently posted warning letters, the U.S. Food and Drug Administration (FDA) put a seafood importer in New York and a processor of thermally processed low-acid foods in Mexico on notice that they have not been adequately following federal regulations. On Aug. 12, 2015, FDA officials in College Park, MD, wrote to Procesamiento Especializado De Alimentos S.A.P.I. De C.V. in Tapachula, Chiapas, Mexico, to tell them that inspectors visiting the seafood processing facility from April 4-6, 2015, found “serious deviations” from the agency’s seafood HACCP regulations, as well as the regulations regarding Emergency Permit Control and Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. FDA WarningThese noted deviations included failure to chlorinate as necessary the container cooler water used in cooling canals and recirculated water supplies, failure to record observations of visual seam closures after pouches are sealed, documenting closure of only the bottom seal of products packed in pouches and not the sides or top seal, and not having a written HACCP plan to control for Staphylococcus aureus growth and toxin formation nor one which lists a critical control point for scombrotixin (histamine) formation during unrefrigerated exposures of the product (thereby risking potential time and temperature abuse). The agency also stated that the company did not visually examine each batch of labels at packaging to make sure that product with and without soy (an allergen) is accurately labeled. FDA acknowledged the company’s response on April 21 but stated that no revised HACCP plan had been included and that other responses were either inadequate or had been incorrectly interpreted. Because of this, the letter told the company that its “pouched tuna products are adulterated.” On Nov. 4, 2015, FDA officials in Jamaica, NY, wrote to Krasnyi Oktyabr USA Inc. in Brooklyn, NY, to state that inspections done June 15-16 and Aug. 5 and 7, 2015, revealed the company had “serious violations” of the seafood HACCP and Current Good Manufacturing Practice regulation for foods. Because of this, the agency stated that the company’s dried salted sprats, dried salted horse mackerel fillets, refrigerated vacuum packaged salted dried bream fish and refrigerated vacuum packaged salted dried Caspian roach (vobla) were adulterated. Specifically, the firm’s HACCP plan for refrigerated vacuum-packaged salted dried bream fish and Caspian roach (vobla) listed a critical temperature limit for receiving product which was not adequate to control the hazard of Clostridium botulinum toxin formation, according to FDA. “For delivery of these types of refrigerated products with transit times exceeding 4 hours total cumulative time, all lots received should be accompanied by transportation records that show the product was held at or below 40 degrees Fahrenheit throughout transit,” FDA’s letter read. Further, the letter stated, the company did not make available for FDA review its receiving records for some products and its records of corrective actions when cooler temperatures exceeded the critical limit on Aug. 1, 3 and 4, 2015. Also, FDA informed the company that its records relating to the processing of its products must be maintained in English. “However, your firm has records that are not in English,” the letter noted. Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law. (To sign up for a free subscription to Food Safety News, click here.)