Warning lettersFDAWarningcolor_406x250 recently made public by the Food and Drug Administration addressed food safety violations at seafood processing operations in Portugal and Peru, dirty equipment and insects at a cider production facility in Kansas and improper use of antibiotics by a dairy in Minnesota.

Recipients of FDA warning letters have 15 days to respond to the agency in writing. Failure to adequately respond can result in orders to cease operations or refusal of imported products at the U.S. border.

Antonio Mineiro e Andrade, Portugal
In a June 28, 2016, warning letter, the FDA’s Center for Food Safety and Applied Nutrition notified plant manager Bdegardo M. Moniz regarding problems discovered at the Antonio Mineiro e Andrade seafood processing facility in Portugal during a Feb. 11-12, 2016, inspection.

At the time the warning letter was went, more than four months after the inspection, the FDA had not received any response from the company regarding the problems cited during the February inspection.

Among the problems cited was the last of a proper seafood HACCP plan (Hazard Analysis and Critical Control Point plan).

“Accordingly, your tuna, bonito, mackerel, jack and sardines are adulterated in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health,” according to the warning letter.

“Moreover, because your firm is not located at the wharf where the fish are unloaded from the harvest vessels, your firm needs to include adequate temperature controls during transit from the harvest vessel to your facility.”

Inadequate measures to ensure that fish the company receives have been held at cold enough temperatures to avoid food safety problems were repeatedly referenced by the FDA inspectors.

Pesquera Nivama SAC, Peru
In an Aug. 30 warning letter, the FDA’s Center for Food Safety and Applied Nutrition told Javier Pacheco Monteverde, co-owner and sales manager at Pesquera Nivama SAC in Lima, Peru, that the seafood processing operation was found to have serious violations of the seafood HACCP regulation during a March 10, 2016, inspection.

“Your responses included flow diagrams and revised HACCP plans for your cooked, frozen, ready-to-eat giant squid — cephalopods — and for your scombrotoxin — histamine — forming species of fish and photographs of your facility. We have evaluated the documentation and found that you have a continuing serious deviation of the seafood HACCP regulation,” according to the Aug. 30 warning letter.

“… your firm’s revised HACCP plan for cooked, frozen, ready-to-eat giant squid does not list the critical control points of cooking and cooling for controlling the food safety hazard of pathogen growth and toxin formation.”

The FDA inspectors noted that the company’s were not properly cooled after cooking to prevent the growth of toxins. The agency also cited the company for failing to have an English-language version of its seafood HACCP plan.

Rees Fruit Farm Inc., Topeka, KS
In a Dec. 5, 2016, warning letter, the FDA’s Kansas City district office told Rex. E. Rees, owner of Rees Fruit Farm Inc., that during visits on Oct. 11, 13, and 14, 2016, inspectors “found significant violation of the FDA’s Current Good Manufacturing Practice (CGMP) regulation in manufacturing, packing or holding human food” in the company’s cider production facility.

“… your firm failed to sanitize food contact surfaces prior to the production of your apple cider on Oct. 10, 2016, and prior to the bottling of that cider on Oct. 11. The last time you sanitized the food contact surfaces was on Sept. 19, 2016. Food contact surfaces include; hoses used to transfer finished apple cider to holding tanks prior to bottling, a plastic watering can used to hold finished apple cider to assist in filling product bottles, the final holding tank prior to bottling, and the cider filling trough used for bottling,” according to the warning letter.

In addition to dirt and other filth on equipment, the inspectors noted “flies too numerous to count were observed landing on production equipment during the bottling of finished apple cider.” The cider manufacturing room does not have a door, leaving it open to the rest of the facility.

Inspectors also noted cats wandering through the warehouse and cider facility, which is a violation of federal law.

Derrek Olson LLC, Plainview, MN
In a Dec. 15, 2016, warning letter the FDA’s Minneapolis district office told dairy owner Derrk Olson that his operation had improperly used an antibiotic on a cow that was sold for slaughter as human food.

The illegal use of the drug flunixin was discovered during inspection visits on Sept. 29 and Oct. 3, 2016. Inspectors discovered through review of the dairy’s records that on Feb. 11, 2016, it had sold a cow for slaughter that was found to have flunixin at 0.632 parts per million (ppm) in the liver tissue. That is far in excess of the legally allowed limit of 0.125 ppm.

The FDA inspectors also found that the dairy failed to document the dosage amount, route of administration, condition being treated, frequency of administration, and the dates for meat/milk withdrawal times as required by federal law.

The dairy also failed to allow enough time between the final dose of the antibiotic and slaughter, which resulted in the illegally high level of drug residue in the meat.

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