March 28, 2024

FDA Warning Letters for the Week of March 20, 2012

The FDA has released its warning letters for the week of March 12, 2012.

1. Fog River, LLC. This seafood processing facility had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. That means the fish processed at the plant are considered adulterated: they were prepared, packed, or held under insanitary conditions whereby they may have ben rendered injurious to health. The company responded to the January warning letter, but did not provide documentation of changes.

2. Zhong Shun Inc. This seafood importer had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. The firm did not have product specifications for frozen roasted eel, and no affirmation that the seafood was processed in accordance with U.S. law.

3. A&M Farms. This farm offered for sale as food an animal that was adulterated. A cow was slaughtered on September 30, 2011 that had penicillin at 0.12 parts per million in the kidneys. That’s above the FDA established tolerance of 0.05 ppm. An inspection found that the farm held animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. In addition, drugs were used in an extralabel manner.

4. Moniz Dairy Farm. This farm also offered for sale as food an animal that was adulterated. A veal calf was slaughtered that had 0.4 ppm penicillin in the kidney, and 83.202 ppm sulfamethazine in the liver. An inspection found that the farm held animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. In addition, drugs were used in an extralabel manner. The owners also provided a signed Livestock Owner’s Certificate that certified none of the livestock shipped had an illegal level of drug residues.

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