April 23, 2024

FDA Warning Letters for Week of March 27, 2012

These are the warning letters the FDA has sent out, published the week of March 27, 2012. These letters warn companies and facilities about violations of food safety and HACCP regulations.

1. Nu Garden, LLC in Taos, New Mexico. This seafood processing facility has violated the seafood Hazard Analysis and Critical Control Points regulations. The company did not have a hazard analysis for each kind of fish. There were no sanitation monitoring records for safety of water, hand washing and sanitizing, labeling, prevention of cross-contamination of ready to eat tuna salads, sandwiches, and sushi rolls, and storage of toxic chemicals, among others.

2. Winn Dixie Logistics, Inc. in Miami, Florida. This facility had serious violations of the seafood HACCP regulation. There was no HACCP Plan filed that lists food safety hazards. The firm’s HACCP plan lists a critical limit of “Product properly iced and in cooler” that isn’t adequate to control pathogenic bacteria growth, and there was no refrigeration temperature. Monitoring procedures were not adequate to control histamine formation. There were issues with receiving crab that was not held on ice, and the facility did not have weekly record reviews.

3. Dale’s LLC in Brighton, Colorado. This alligator processing facility had violations of the seafood HACCP regulation. There was no hazard analysis for each kind of fish, and no HACCP plan for canned alligator to control the food safety hazard of pathogen growth and major food allergens. The company responded, but with no supporting documentation.

4. Sir Pizza of Tennessee, Inc. in Murfreesboro, Tennessee. This pizza restaurant violated the FDA’s current Good Manufacturing Practice requirements. Pests were not excluded from processing areas. There was evidence of widespread rodent activity in, on, and near foods stored in the warehouse, packing room, and ingredient store room. Two dead rodents were on the floor in the cardboard pizza rounds storage area. Rodent pellets were found on storage racks holding food. At least 235 rodent pellets were found in the dough production room and in storage areas. Non-food contact surfaces of dough machines were heavily soiled, with brown oil and debris. The concrete floor was damaged and pitted, making it difficult to clean. Buildings were not maintained in a sanitary condition. And eight exposed green rodent bait blocks were found under food storage shelves, under packaging materials for pizza dough and spaghetti sauce, and next to the water heater. The facility was also not registered with the FDA.

5. Box Canyon Dairy in Wendell, Idaho. this dairy offered an animal for slaughter as food that was adulterated. A dairy cow had 0.25 parts per million (PPM) of sulfadimethoxine in the liver tissue. The FDA limit for that drug is 0.1 PPM. The farm held animals that were so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Complete treatment records were not maintained. And drugs were used in a manner not as directed by approved labeling.

6. Double Aught Dairy, LLC in Dexter, New Mexico. This dairy offered an animal for slaughter as food that was adulterated. The dairy cow had 0.17 PPM of Penicillin in its kidneys. The level set for that drug is 0.05 PPM. This farm had been warned in 2007 about the same issue, but for the drug Flunixin.

7. Crystal Bay Seafoods, Inc. of Green Bay, Wisconsin. This seafood processing facility did not have a HACCP plan for Albacore Tuna, Wahoo, bluefin Tuna, Escolar, Amberjack, Mahi Mahi, Herring fillets in wine sauce, and creamed Herring fillets to control histamine formation. They also did not have a HACCP to control Clostridium botulinum growth in vacuum packed imitation crab meat (surimi) and pasteurized canned Blue Swimming Crab Meat.

8. J.M.Smucker LLC of Orrville, Ohio. This facility manufactures and distributes acidified food products. This firm did not process the acidified product in conformity with scheduled process for Pumpkin Butter. They also did not have trained personnel conducting operations required for control of the scheduled process. The trained individual must be on-site during production. Several products were not evaluated by a process authority.

9. Sullivan Lane Farm of Springs, Pennsylvania. this farm offered an animal for slaughter as food that was adulterated. The dairy cod had 0.288 PPM Sulfamethazine residue in the liver. There is no tolerance for this drug, so its presence causes the food to be adulterated. The farm also failed to maintain treatment records.

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