FDA WARNING_LETTER - De Jong Dairy, Inc. - May 24, 2011

On July 6, 2011, the FDA issued a Warning Letter to De Jong Dairy, Inc. following an investigation on May 18 and 24, 2011, at their Hickory Corners, Michigan, dairy operation. The letter identified violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on or about September 1, 2010, De Jong Dairy sold a cow (ear tag (b)(4)) for slaughter that was found to have Sulfamethazine in its liver tissue at 0.117 ppm, exceeding the FDA tolerance of 0.1 ppm (21 CFR 556.670). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)].

Furthermore, the investigation revealed insanitary conditions, including a failure to maintain complete treatment records for medicated animals, increasing the likelihood of harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].

The letter also cited a violation of section 301(h) of the Act [21 U.S.C. § 331(h)] for