FDA WARNING_LETTER - WHB Cattle, LP (Braum Dairy Farms) - April 20, 2011

On April 19-20, 2011, the FDA inspected W.H. Braum, Inc.'s dairy operation, WHB Cattle, LP, in Follett, Texas. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on February 10, 2011, the firm sold a dairy cow for slaughter that was found to have Penicillin at 0.4 ppm in its kidney tissue, exceeding the established tolerance of 0.05 ppm (21 C.F.R. § 556.510). This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act.

Additionally, the firm held animals under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply. This constitutes adulteration under section 402(a)(4) of the Act. Deficiencies included incomplete treatment records lacking drug dosage, route of administration, withdrawal times, and administrator's identity. Furthermore, handwritten and electronic records for the implicated cow conflicted on the last treatment date (January 21, 2011, vs. January 23, 2011).

W.H. Braum, Inc. is responsible for ensuring compliance and must take prompt action to correct these violations and prevent recurrence. Failure to do so may result