FDA WARNING_LETTER - Dominguez Farms Inc. - April 03, 2015

On March 31, 2015, and April 1-3, 2015, the FDA inspected Dominguez Farms, Inc. and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation was the sale of an adulterated dairy cow for slaughter on January 12, 2015. USDA/FSIS analysis of the cow's liver tissue on January 13, 2015, revealed 0.192 ppm of sulfadimethoxine, exceeding the FDA tolerance of 0.1 ppm, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also found that the farm held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating 21 U.S.C. § 342(a)(4). Specifically, the farm failed to maintain complete treatment records and verify withdrawal times before slaughter.

Furthermore, the new animal drug sulfadimethoxine was adulterated under 21 U.S.C. § 351(a)(5) because it was used extralabelly without veterinary supervision, violating 21 CFR 530.11(a) and resulting in an illegal drug residue, violating 21 CFR 530.11(d