FDA WARNING_LETTER - Providence Dairy, LLC - September 28, 2009

On September 10 and 28, 2009, the FDA inspected Providence Dairy, LLC, owned by Mr. Arie Jan de Jong. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

The FDA found that Providence Dairy offered for sale animals for slaughter as food that were adulterated. Specifically, five cows sold between May and July 2009 were found to have illegal drug residues in their tissues, including penicillin, sulfadimethoxine, neomycin, and flunixin, exceeding established tolerances. This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act.

The investigation also found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, due to a failure to maintain complete treatment records. This is a violation of section 402(a)(4) of the Act.

Furthermore, Providence Dairy adulterated new animal drugs by using penicillin, flunixin, neomycin, and sulfadimethoxine in an extralabel manner, not as directed by approved labeling. These extralabel uses were not under the supervision of a licensed veterinarian and resulted in illegal drug residues, violating 21 C.F.R. Part 530. Sulfadimethoxine was also used extralabelly in lactating dairy cattle, which is prohibited. These actions caused the drugs to be unsafe and adulter