FDA WARNING_LETTER - Manuel Gaspar & Son Dairy - September 07, 2012

On November 15, 2012, the FDA issued a Warning Letter to Manuel Gaspar & Son Dairy following an investigation on September 5 and 7, 2012. The investigation found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a bob veal calf sold for slaughter on May 10, 2012, was found to have neomycin at 19.58 ppm in the kidney and sulfamethoxazole at 1.487 ppm in the liver and 2.986 ppm in the muscle tissue. This is in violation of 21 U.S.C. § 342(a)(2)(C)(ii) because the neomycin residue exceeded the 7.2 ppm tolerance for cattle kidney, and no tolerance exists for neomycin or sulfamethoxazole in bob veal calves.

The dairy also failed to maintain complete treatment records, leading to adulterated food under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Furthermore, the new animal drug (b)(4) (neomycin sulfate) and the human drug Sulfamethoxazole and Trimethoprim (SMZ/TMP) Tablets, USP (b)(4), were used in an extralabel manner without veterinary supervision, violating 21 C.F.R. 530.11(