The Food and Drug Administration recently sent warning letters to a Nebraska dairy and a seafood processor in Thailand because inspectors found significant violations of U.S. food safety laws at their operations.

Businesses have 15 days to respond in writing to the FDA after receiving a warning letter. If they don’t correct the violations, the FDA can take action up to and including shutting down operations.

Dolezal Dairy — Pender, NE
Inspectors found excessive antibiotic levels, incomplete records, and conditions at the dairy that make it possible for illegal cows to enter the human food supply.

The FDA sent a warning letter dated Aug. 29 to the dairy co-owners, Jeffery A. Dolezal, Mark G. Dolezal and Mark R. Dolezal informing them that testing showed they had sold a cow for slaughter on March 22 that was contaminated with “a new animal drug that is unsafe.” The drug ceftiofur was discovered when a marker residue, desfuroylceftiofur, showed up in results from U.S. Department of Agriculture testing.

Another drug, which had been used illegally, was also found in the cow’s tissue.

“Our investigation found you administered Excede, a ceftiofur crystalline free acid, to a dairy cow with ear tag (number redacted) without following the indications for use and withdrawal time as stated in the approved labeling. You admitted to using Excede for unapproved uses including treating (the) cow with (number redacted) for treatment of diarrhea and fever. Excede is not approved for treatment for diarrhea and fever,” according to the warning letter.

“Also, you admitted to entering the wrong date in your calendar, which caused you to sell the cow (number redacted) before the end of the meat withdrawal period specified in the approved labeling. Your extra-label use of Excede (ceftiofur crystalline free acid) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a), and resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d).”

When FDA inspectors checked conditions at the dairy June 5-11, they found multiple violations. Those violations included:

  • The presence of desfuroylceftiofur at 8.649 parts per million. Federal law sets a tolerance of only 0.4 ppm for residues of desfuroylceftiofur in uncooked edible tissues of cattle;
  • An inadequate record system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues; and
  • A false guaranty, violating federal law, was signed by co-owner Mark R. Dolezal certifying that none of the dairy’s livestock delivered for slaughter will have an illegal level of drug residues or the producer will inform the buyer of any drugs the livestock have been given.

Natural Sea Product Co. Ltd. — Thailand
In a warning letter dated Sept. 4, the FDA informed owner Paramesawa Sornsong that his company’s production of shelf-stable, vacuum-packaged dried fish products will be detained at the U.S. border if violations of food safety laws are not resolved.

The owner previously responded to FDA regarding the violations, but the agency warning letter says the new measures he described are inadequate to meet legal requirements.

Violations documented by FDA inspectors included, but are not limited to:

  • A lack of a HACCP plan to ensure the safety of the dried fish products, which can render food unsafe for human consumption because of biological, chemical, or physical properties;
  • The production procedures do not list the food safety hazard of natural toxins, e.g. ciguatera toxin, which is reasonably likely to occur in yellow stripe trevally caught in tropical and subtropical waters — primary processors need food safety controls for receiving fish directly from the harvest vessels; and
  • Failure to control refrigerated storage to ensure that products held for extended time periods in-process are stored continuously at a temperature of 4.4° C or below to prevent the formation of scombrotoxin.

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