FDA WARNING_LETTER - Triple G Dairy - March 30, 2010

On July 6, 2010, the FDA issued a Warning Letter to Triple G Dairy following an investigation from March 22-30, 2010. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a dairy cow sold for slaughter on January 4, 2010, and slaughtered on January 5, 2010, was found to have 0.76 ppm of sulfadimethoxine residue in its liver, exceeding the FDA tolerance of 0.1 ppm. This rendered the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The dairy also failed to maintain complete treatment records for medicated animals, specifically for the cow in question, lacking information on meat/milk withhold times, route of administration, and the identity of the administrator. This constitutes insanitary conditions, leading to adulterated food under section 402(a)(4) of the Act.

Furthermore, the new animal drug Albon (sulfadimethoxine) boluses were used extralabelly without following approved labeling directions, violating 21 C.F.R. Part 530. This extralabel use was not by or on the lawful order of a licensed veterinarian within a valid veterinarian/client/patient relationship, and sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle (21