FDA WARNING_LETTER - Renati Dairy - November 28, 2012

On November 20, 21, and 28, 2012, the FDA inspected Renati Dairy in Petaluma, California, and found significant violations of the Federal Food, Drug, and Cosmetic Act. The investigation revealed that the dairy adulterated new animal drugs, specifically penicillin G procaine injectable suspension, furosemide injection, and flunixin meglumine injectable solution, by using them in an extralabel manner not directed by their approved labeling. Key deficiencies included administering penicillin G procaine without following dosage, conditions for use, and withdrawal times, and without licensed veterinary supervision, violating 21 C.F.R. 530.11(a). Furosemide injection was routinely administered without adhering to the specified milk withdrawal period or licensed veterinary supervision, also violating 21 C.F.R. 530.11(a). Similarly, flunixin meglumine injectable solution was used without following the approved route of administration or licensed veterinary supervision, again violating 21 C.F.R. 530.11(a). These extralabel uses, not complying with 21 C.F.R. Part 530, rendered the drugs unsafe under 21 U.S.C. 360b(a) and adulterated under 21 U.S.C. 351(a)(5). Renati Dairy is required to take prompt corrective action and notify the FDA within fifteen working days, detailing steps taken to correct violations and prevent recurrence, with potential regulatory actions like seizure or injunction for non-compliance.