FDA WARNING_LETTER - 4-Way Dairy, LLC - January 10, 2013

On January 7-10, 2013, the FDA inspected 4-Way Dairy, LLC, finding violations of the FD&C Act. A dairy cow sold for slaughter on July 13, 2012, and slaughtered on July 19, 2012, contained 0.14 ppm of penicillin in kidney tissue, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510), rendering the food adulterated under section 402(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records and verify withdrawal times before slaughter, leading to potentially harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4).

Furthermore, the new animal drug (b)(4) was adulterated because it was used extralabelly without veterinary supervision and resulted in an illegal drug residue, violating 21 C.F.R. 530.11(a) and (d). This non-conformance with approved labeling and 21 C.F.R. Part 530 made the drug unsafe under section 512(a) and adulterated under section 501(a)(5).

4-Way Dairy, LLC must take prompt action to correct these violations and establish