The most recently posted warning letters from the U.S. Food and Drug Administration went to a seafood exporter in Indonesia, a beef operation in Missouri, an acidified foods manufacturer in Virginia, a vegetable processor in Washington state, and a California firm with a contracted seafood storage warehouse in Colorado.
PT Tritunggal Lintas Benua in Jakarta, Indonesia, was told in a July 26 warning letter that its submitted Hazard Analysis and Critical control Point (HACCP) plan for its tuna exporting operation does not meet the requirements of U.S. seafood HACCP regulations.
tunaloins-iphone“Accordingly, your fish products covered by your HACCP plan entitled ‘Frozen Tuna Product’ that includes yellowfin tuna loin, saku, steak, and cubes are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health,” the letter stated.
FDA detailed “serious deviations” from federal regulations in the company’s HACCP plan, including not listing the food safety hazard of Clostridium botulinum growth and toxin formation.
Other concerns cited in the warning letter were not listing the critical control points of raw material storage, in-process storage and unrefrigerated processing for controlling the food safety hazard of scombrotoxin, or histamine, formation.
FDA sent a July 19 warning letter to Mark Northcutt notifying him of violations of the Federal Food, Drug, and Cosmetic Act found during an investigation of his beef cow-calf operation in Laddonia, MO.
A cow sold for slaughter as food on or about March 21 was found to have 0.744 parts per million of penicillin in tissue samples. “FDA has established a tolerance of 0.05 ppm for residues of Penicillin in the edible tissues of cattle …,” the letter stated.
HomeCannedPeppersMainOliverio’s Italian Style Peppers Inc. was sent a warning letter on July 19 noting “serious deviations” from the acidified foods regulations found during a March inspection of the company’s manufacturing facility in Clarksburg, WV.
The letter stated that the deviations included failure to file a scheduled process with the agency for “Medium Hot Peppers & Onions With Tomato Sauce” and listing vinegar as an ingredient in several products when “vinegar was not used during the manufacture of these products and instead the tomato ingredients are the acidifying agent” in the products.
FDA also mentioned misbranding problems such as nutrition information not listed in an appropriate format, along with serving size problems and failure to list certain ingredients, such as sugar, on the label while listing others, such as vinegar and olive oil, which were not added during product manufacturing.
The agency concluded that the company’s reply on March 21 lacked sufficient corrective actions regarding both the processing and the labeling.
“Your firm’s response states that you will work with your process authority to correct these violations; however, at this time, we have not received any updated scheduled process submissions from your firm,” the warning letter said.
frozen-vegetablesA warning letter went out July 15 to Oregon Potato Co., doing business as Freeze Pack, detailing numerous problems FDA found during a March 8-11 inspection of the company’s vegetable processing facility in Pasco, WA.
These problems included Listeria bacteria found at several places in the plant, plus a number of Current Good Manufacturing Practice (CGMP) violations.
Food Safety News posted a separate story on Aug. 4 about the FDA warning letter to Oregon Potato Company.
On July 13, FDA sent a warning letter to DPI Specialty Foods Inc. of Ontario, CA, to notify the company of seafood HACCP problems identified March 29 at the company’s contracted warehouse facility in Henderson, CO. The agency noted that a warehouse used for storing food products is considered a “processor” under federal seafood HACCP regulations.
Barring an adequate seafood HACCP plan, “your raw Herring in Sour Cream and Herring Party Sampler are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health,” the warning letter stated.
FDA’s warning stated that deviations found during the agency’s inspection include not listing for refrigerated seafood the critical control points of receiving, storage, and shipping for controlling the food safety hazard of scombrotoxin, or histamine.
Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.
