FDA WARNING_LETTER - Spaletta Ranch - February 28, 2012

On February 15, 21, and 28, 2012, the FDA investigated Spaletta Ranch, a dairy operation in Petaluma, California. The investigation found violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the adulteration of new animal drugs.

Specifically, Spaletta Ranch was found to have used (b)(4) (gentamicin sulfate solution) and (b)(4) (penicillin G procaine injectable suspension) in an extralabel manner, violating 21 CFR 530.3(a). The extralabel use of these drugs was not in compliance with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 CFR Part 530, which requires such use to be by or on the lawful order of a licensed veterinarian within a valid veterinarian/client/patient relationship.

The ranch administered (b)(4) (gentamicin sulfate solution) to three dairy cows without following the animal class, indications for use, and withdrawal period specified in the servicing veterinarian’s prescription. Additionally, (b)(4) (penicillin G procaine injectable suspension) was administered without adhering to the approved labeling's indications for use, dosing frequency, dosage amount, and dosage amount per