FDA WARNING_LETTER - Roes Haven Farm - October 05, 2007

An FDA inspection of Roes Haven Farm's dairy operation on October 3 and 5, 2007, revealed significant violations. The firm offered a cow for slaughter as food that was adulterated, containing 8888.0 ppb of phenylbutazone in kidney tissue, a drug with no established tolerance in cattle, violating 21 U.S.C. 342(a)(2)(C)(ii). This adulteration stemmed from the farm's inadequate system to ensure medicated animals are withheld for appropriate withdrawal periods, making food from such animals adulterated under 21 U.S.C. 342(a)(4). Furthermore, the new animal drug Phenylbutazone Injection 20% was adulterated under 21 U.S.C. 351(a)(5) because it was used in a manner not conforming to its approved labeling. Specifically, the extralabel use of phenylbutazone failed to comply with 21 C.F.R. Part 530, including administering it to a female dairy cow over 20 months of age, which is prohibited by 21 C.F.R. 530.41(a)(12), and resulting in an illegal drug residue, violating 21 C.F.R. 530.11(c). These actions rendered the drug unsafe under 21 U.S.C. 360b(a). Roes Haven Farm must take prompt corrective action, establish preventative procedures, and respond to the FDA within fifteen working days detailing their compliance plan and documentation to avoid further regulatory action like seizure or injunction.