FDA WARNING_LETTER - Chris De Jong Dairy LLC - August 24, 2012

On October 11, 2012, the FDA issued a Warning Letter to De Jong Dairy following an investigation conducted on August 22, 23, and 24, 2012. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

A dairy cow sold for slaughter on April 25, 2012, was found to have 0.09 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 FD&C Act.

The dairy also failed to maintain complete treatment records, leading to insanitary conditions where medicated animals with potentially harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, De Jong Dairy adulterated the new animal drug Pen-Aqueous (Penicillin G Procaine) Injectable Suspension by using it extralabelly without the supervision of a licensed veterinarian and not adhering to the approved dosage and injection site limitations. This resulted in an illegal drug residue, violating 21 C.F.R. 530.11(a) and (d), and causing the