Walk, Ed – FDA Warning Letter, Nov 15, 2012

On November 15, 2012, the FDA inspected Ed Walk Farm, a hog farrowing operation, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated sow for slaughter, which contained violative residues of nafcillin and penicillin in its kidney. FDA has a zero tolerance level for these drugs in uncooked edible swine tissue, making the food adulterated under Section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the investigation revealed insanitary conditions under Section 402(a)(4) of the FD&C Act, specifically the failure to maintain complete treatment records and a drug inventory system. These deficiencies indicate that medicated animals with potentially harmful drug residues are likely to enter the food supply.

Ed Walk Farm is required to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective steps, including documentation, must be submitted to the FDA within fifteen working days of receiving the letter. Failure to comply may result in regulatory actions such as seizure or injunction.