FDA WARNING_LETTER - Elam Fisher - August 20, 2013

On October 31, 2013, the FDA issued a Warning Letter to Mr. Elam Fisher, owner of a dairy operation in Rising Sun, MD, following an investigation conducted from July 30 to August 20, 2013. The investigation revealed that an animal sold for slaughter on November 21, 2012, contained 0.75ppm of Desfuroceftiofur in its edible tissues, exceeding the tolerance level of 0.4ppm (21 C.F.R. 556.113). This rendered the food adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the FD&C Act.

The FDA found that the operation lacked an adequate system to prevent medicated animals with harmful drug residues from entering the food supply. Deficiencies included failure to maintain treatment records, identify and record purchased animals sold for slaughter, and an inadequate drug inventory system.

Furthermore, Mr. Fisher adulterated Excenel RTU (ceftiofur hydrochloride sterile suspension) by using it in an extralabel manner without following approved dosage levels and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). This extralabel use resulted in an illegal drug residue, violating 21 C.F.R.