FDA WARNING_LETTER - Blue Jay Dairy - May 23, 2011

On May 18-23, 2011, the FDA inspected Blue Jay Dairy in Dublin, Texas. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act. Specifically, on December 8, 2010, Blue Jay Dairy sold a dairy cow for slaughter that was found to have an illegal residue of Flunixin in its liver at (b)(4) ppm, exceeding the tolerance level of 0.125 ppm. This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), as it contained an unsafe new animal drug.

Furthermore, the investigation found that animals were held under insanitary conditions, specifically due to the failure to maintain treatment records for medicated cattle. This practice increases the likelihood of medicated animals with harmful drug residues entering the food supply, thus adulterating the food under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

Blue Jay Dairy is required to take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective actions, including documentation, must be submitted to the FDA within fifteen working days of receiving the letter