FDA WARNING_LETTER - Stoltzfus, Jacob F.

On November 4, 2013, the FDA conducted an investigation of Jacob F. Stoltzfus's dairy operation in Lititz, PA, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The inspection revealed that an animal offered for slaughter as food was adulterated. Specifically, a dairy cow sold on or about June 10, 2013, was found to have penicillin residues at (b)(4) ppm in the kidney (tolerance 0.05 ppm, 21 C.F.R. 556.510) and flunixin residues at (b)(4) ppm in the liver (tolerance 0.125 ppm, 21 C.F.R. 556.286(b)). This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act due to unsafe new animal drug residues. Additionally, the firm was found to hold animals under inadequate conditions, making it likely that medicated animals with harmful drug residues enter the food supply, violating section 402(a)(4) of the Act. A specific deficiency noted was the failure to maintain treatment records. The FDA requires prompt corrective action and the establishment of procedures to prevent recurrence. A written response detailing these steps, including documentation, is required within fifteen working days to avoid potential regulatory actions like seizure or injunction.