FDA WARNING_LETTER - correia family limited partnership ( - November 19, 2012

On March 4, 2013, the FDA issued a Warning Letter to Correia Family Limited Partnership dba Wynsum Holsteins following an investigation on October 19 and November 19, 2012. The investigation found violations of the Federal Food, Drug, and Cosmetic Act.

A heifer sold for slaughter on May 4, 2012, was found to have 12.96 ppm of desfuroylceftiofur in kidney tissue, exceeding the FDA tolerance of 0.4 ppm, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The operation also held animals under insanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. 342(a)(4).

Furthermore, the firm adulterated new animal drugs by using them extralabel without veterinary supervision, violating 21 C.F.R. 530.11(a). Specifically: - **Excede (ceftiofur crystalline free acid) Sterile Suspension:** Administered to a heifer without following dose and withdrawal period, resulting in an illegal residue (21 C.F.R. 530.11(d)) and violating the prohibition on extr