FDA WARNING_LETTER - Edelweiss Farms, Inc. - April 28, 2011

On April 6 and 28, 2011, the FDA conducted an investigation of Edelweiss Farms, Inc., identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the adulteration of the new animal drug flunixin meglumine (Flunazine, Injectable Solution, ANADA#200-387). The investigation revealed the firm engaged in extralabel use of flunixin by not adhering to the approved labeling, specifically administering the drug to a dairy cow without following the prescribed dose and withhold times. Crucially, this extralabel use was not conducted under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). This non-compliance with approved labeling and 21 C.F.R. Part 530 rendered the drug unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. As a producer of food animals, the firm is responsible for ensuring overall compliance. Edelweiss Farms, Inc. must promptly correct these violations and implement procedures to prevent recurrence. A written response detailing corrective actions, timelines, and supporting documentation is required within fifteen working days to avoid potential regulatory actions like seizure or injunction.