FDA WARNING_LETTER - Graham Dairy - October 19, 2012

On October 16-19, 2012, the FDA inspected Graham Dairy in Kentwood, Louisiana, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary issue was the sale of an adulterated cow for slaughter on August 14, 2012. USDA/FSIS analysis of tissue samples from this animal, slaughtered on August 16, 2012, revealed 1.90 ppm of penicillin in kidney tissue (tolerance 0.05 ppm) and 5.449 ppm of tilmicosin in liver tissue (tolerance 1.2 ppm). Furthermore, FDA has no established tolerance for Micotil 300 Tilmicosin Injection in female dairy cattle 20 months or older. These drug residue levels caused the food to be adulterated under Section 402(a)(2)(C)(ii) of the Act.

The investigation also found insanitary conditions, specifically the lack of an adequate system to ensure medicated animals were withheld from slaughter for appropriate withdrawal periods, leading to potentially harmful drug residues entering the food supply. This included a failure to maintain treatment records, rendering food adulterated under Section 402(a)(4).

Additionally, the dairy adulterated new animal drugs (Penicillin G Procaine, Tilmicosin, and Penicillin G Procaine/Dihydrostreptomycin Sulfate) by using them extr