In an April 11 warning letter to owner James Darren Hudson, the FDA described violations observed during inspection visits on Feb. 5, 13, and 14 at the James D. Hudson Livestock operation in Caneyville, KY. Investigators found that the firm holds animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the human food supply.

Inspectors from the Food and Drug Administration conducted an investigation of the firm’s beef cattle grower operation as a follow-up after residue of ciprofloxacin was found in a slaughtered cow. “… under the AMDUCA provisions, FDA has the right to prohibit extra-label uses of certain drugs in food animals if the extra-label use of the drug or class of drugs presents a risk to human health, including antimicrobial resistance,” according to the warning letter.

The Kentucky livestock operation lacks a system to ensure that the animals medicated there have been withheld from slaughter for appropriate periods of time to permit depletion from edible tissues of potentially hazardous drug residues, the warning letter states. The cattle rancher failed to maintain treatment records and lacked an adequate system to identify animals that have been medicated.

The FDA also noted that the firm reuses syringes that are contaminated with other medications. A bottle of the [redacted] containing animal drug “[redacted] injectable solution” observed at the firm was a brown color although it is supposed to be [redacted] liquid.

The owners stated the [redacted]-containing animal drug “[redacted] injectable solution” was discolored because they reused a syringe that still contained the [redacted] containing animal drug “[redacted].” The FDA said the operators must protect the drugs in use at their firm from contamination. Furthermore, they must maintain syringes they use to administer injectable solutions in a well-cleaned state through appropriate cleaning and sanitation procedures.

Additionally, FDA officials found expired drugs in the firm’s drug storage. The FDA documented drugs that had expired in January of 2015, March of 2016, August of 2017, and September of 2018.

FDA investigators added that the above is not intended to be an “all-inclusive list of violations,” and that as a producer of animals offered for use as food, the firm is responsible for ensuring that their overall operation and the food they distribute is in compliance with the law.

“You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur,” the FDA advised.

Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.