FDA WARNING_LETTER - Stardell Farms Inc - February 07, 2013

On February 5th and 7th, 2013, the FDA inspected Holstein Marketing Center of Iowa, Inc.'s dairy operation, identifying several violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale an animal for slaughter with adulterated food tissue, specifically a dairy cow containing 0.65 ppm of desfuroylceftiofur in its kidney, exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. § 556.113), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Additionally, the firm held animals under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act; this was exemplified by a failure to maintain complete treatment records. The new animal drug (b)(4) was also found to be adulterated because it was not used as directed by its approved labeling, constituting an extralabel use. The firm administered (b)(4) to a dairy cow without following the prescribed dose and frequency, which is prohibited for extralabel use in cattle by 21 C.F.R. 530.41(a)(13) and resulted in an illegal drug residue, violating 21 C.F.R. § 530.11(d). This non-conformance caused the drug to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act. The FDA requires prompt corrective action and establishment of preventative procedures, with a written response due within fifteen working days detailing steps taken or planned, including documentation, to avoid further regulatory action like seizure or injunction.