FDA WARNING_LETTER - R-Dream Farms, LLC. - May 01, 2015

The FDA inspected R-Dream Farms, L.L.C. on April 29 and May 1, 2015, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on August 5, 2014, contained illegal cefazolin residues in its kidney, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). The firm also maintained animals under insanitary conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, a violation of 21 U.S.C. 342(a)(4). This was exacerbated by a lack of a drug administration control system and incomplete treatment records. Furthermore, the firm adulterated the human drug (b)(4) through extralabel use not directed by approved labeling or a veterinarian's prescription (21 C.F.R. 530.3(a)). This extralabel use lacked licensed veterinary supervision (21 C.F.R. 530.11(a)), resulted in illegal residues (21 C.F.R. 530.11(c)), and involved a drug prohibited for extralabel use in cattle (21 C.F.R. 530.41(a)(13)(iii)). These actions rendered the drug unsafe and adulterated (21 U.S.C. 360b(a), 351(a)(5)). R-Dream Farms must promptly correct these violations and establish preventative procedures. A written response detailing corrective actions, including documentation and timelines, is required within fifteen working days to avoid potential regulatory actions like seizure or injunction.