FDA WARNING_LETTER - J & S Dairy Farm Inc. - March 19, 2008

An FDA inspection of J & S Dairy Farm Inc. on March 18-19, 2008, confirmed the sale of an adulterated dairy cow for slaughter. On December 5, 2007, a cow sold by J & S Dairy was slaughtered, and USDA/FSIS analysis found penicillin at 0.10 ppm in kidney tissue, exceeding the 0.05 ppm tolerance (21 C.F.R. § 556.510). This constitutes adulteration under section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection also revealed inadequate conditions, indicating that medicated animals with potentially harmful drug residues are likely to enter the food supply. Specifically, the firm lacked an adequate system to ensure appropriate drug withdrawal periods, exemplified by a failure to maintain complete treatment records. This violates section 402(a)(4) of the Act.

A Form FDA 483, Inspectional Observations, was issued and discussed. J & S Dairy Farm Inc. must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory action, including seizure and/or injunction. A written response detailing corrective actions and timelines is required within fifteen working days of receiving the letter.