FDA WARNING_LETTER - Vaqueria Paso Real - January 18, 2008

An FDA inspection of Vaqueria Paso Real dairy farm on December 20, 2007, and January 18, 2008, revealed violations concerning the unsafe and adulterated use of new animal drugs [redacted], [redacted], and [redacted]. The farm's extralabel drug use failed to conform with approved labeling and 21 CFR Part 530.

Specifically, [redacted] was administered without adhering to the withdrawal period and without licensed veterinarian supervision, violating 21 CFR 530.11(a), and resulted in an illegal drug residue, violating 21 CFR 530.11(d). Additionally, [redacted] was administered to lactating dairy cows via an unapproved route (not intravenous), which is prohibited under 21 CFR 530.41(9), and also resulted in an illegal drug residue, violating 21 CFR 530.11(c). These actions rendered the drugs unsafe under section 512(a) and adulterated under section 501(a)(5) of the Federal Food, Drug, and Cosmetic Act.

The FDA requires prompt corrective action to prevent recurrence, including establishing procedures to ensure food with harmful drug residues does not enter the food supply. Failure to comply may lead to regulatory actions like seizure or injunction. A written response detailing corrective steps and timelines is required