FDA WARNING_LETTER - Langeland Farms - September 17, 2012

On November 13, 2012, the FDA issued a Warning Letter to Langeland Farms following an investigation on September 7 and 17, 2012, of their dairy operation in Coopersville, Michigan. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a dairy cow sold for slaughter on February 20, 2012, was found to have 0.17 ppm of penicillin in its kidney tissue, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The FDA also found that Langeland Farms held animals under insanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the Act.

Furthermore, the farm engaged in extralabel use of the new animal drug Agri-Cillin (Penicillin G Procaine) Injectable Suspension (NADA 065-010) without following approved labeling for dose, injection site limitation, indication, and withdrawal period. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R.