FDA WARNING_LETTER - Diamond W Ranch - April 24, 2014

On April 22 and 24, 2014, the FDA investigated Diamond W Ranch, a dairy operation in Petaluma, California. The investigation found that the ranch adulterated new animal drugs by not using them as directed by their prescription labels or approved labeling, constituting extralabel use.

Specifically, the ranch administered Flunixin Meglumine, Penicillin G Procaine, Isoflupredone Acetate, and Ceftiofur to dairy cows without following the prescribed route of administration, dosage, dosage per injection site limitation, or withdrawal timeframe. These extralabel uses were not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). Additionally, the extralabel use of Ceftiofur for an unapproved route of administration in cattle is prohibited by 21 C.F.R. 530.41(a)(13)(ii).

These actions caused the drugs to be unsafe under section 512(a) of the FD&C Act and adulterated under section 501(a)(5). The FDA requires prompt corrective action within fifteen working days, including steps taken to correct violations and prevent recurrence. Failure to comply may result in regulatory action such as seizure and/or injunction.