FDA WARNING_LETTER - Zunker, Andrew G. - December 04, 2014

On December 3 and 4, 2014, the FDA investigated R & Z Farms, Inc. and found violations of the Federal Food, Drug, and Cosmetic Act. The company offered for sale an adulterated dairy cow for slaughter on September 22, 2014. USDA/FSIS analysis of tissue samples from this animal revealed penicillin at 1.548 ppm in the kidney, exceeding the 0.05 ppm tolerance, and detected oxyphenylbutazone, a phenylbutazone metabolite, for which no tolerance exists.

The investigation also found insanitary conditions, specifically a failure to maintain treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply. Furthermore, the company adulterated new animal drugs, specifically "Albadry Plus" (sterile penicillin G procaine injectable suspension) and Phenylbutazone (phenylbutazone tablets), by using them extralabelly without veterinary supervision. Penicillin G procaine was administered without following dosage, injection site amount, and slaughter withhold period, resulting in illegal residues. Phenylbutazone was administered without following the approved animal class, also resulting in illegal residues. Phenylbutazone is prohibited for extralabel use in female dairy cattle 20 months or older. These extralabel uses caused the drugs to be unsafe and adulterated.

Additionally, on September 22, 2014, the company provided a false guaranty on a delivery