Top Reasons for Warning Letters

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February 25, 2015


• Categories: Compliance, Food Manufacturing

The U.S. Food and Drug Administration (FDA) sent warnings to three beef producers, one pork producer, a seafood processor and a biscuit manufacturer in its latest round of warning letters.

Some of the beef producers and dairy farms received warning letters for drug residues found in their meat:

• Oak Hill Farms of Seward, PA, received a warning letter for selling a bob veal calf in July 2014, testing of which revealed neomycin, a drug that has no acceptable tolerance level.
• Schneider Dairy of Westphalia, MI, was found to have sold a dairy cow for slaughter in February 2014 that contained more than 10 times the tolerance level for for desfuroylceftiofur, marker residue for the drug ceftiofur. FDA also found that the dairy failed to maintain complete drug treatment records and lacked clear directions from its veterinary clinic on using the drug.
• Stonegate Farms, sold a cow for slaughter in July 2014 that was found to have 13 times the tolerable level of penicillin in its kidneys and nearly 100 times the tolerable level of sulfadimethoxine in its liver. That dairy also failed to maintain complete treatment records of its cattle, according to FDA.
• Poeppelman Pork of Yorkshire, OH, was also found to have sold an animal for slaughter with excessive levels of drugs in its tissues. In February 2014, the pork producer allegedly sold a pig for slaughter that was found to have penicillin in its kidneys. FDA’s letter noted there is no tolerance level of penicillin in swine.

Yamahide Shokuhin, a seafood processor and exporter in Miki-shi, Japan, was cited for having inadequate HACCP plans. The company was also found to have “significant deviations” from requirements, including a number of incomplete food safety plans for its dried shaved bonito product.

NP Foods Ltd., headquartered in Riga, Latvia, was cited for having several wafer and biscuit products that were mislabeled, all related to incomplete nutritional information. The company also failed to include the common or usual name of the foods on the labels in English.

In each letter, FDA requested that the companies provide written responses detailing steps taken to bring the facilities into compliance with food-safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence. The companies are given 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.