FDA WARNING_LETTER - Bella Holsteins, Incorporated - July 31, 2013

On July 23, 29, and 31, 2013, the FDA investigated Bella Holsteins, Inc. in Platteville, Colorado, and found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on April 4, 2013, Bella Holsteins sold a dairy cow (ear tag (b)(4)) for slaughter that contained 1.27 ppm of desfuroylceftiofur in kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 CFR 556.113(b)(3)(1)). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records and verify withdrawal times, leading to adulterated food under section 402(a)(4) of the FD&C Act.

Furthermore, Bella Holsteins adulterated the new animal drug (b)(4) (ceftiofur sodium, (b)(4)) by using it extralabelly without veterinary supervision and failing to observe the withdrawal period, resulting in illegal drug residues. This violates 21 CFR 530.11(a) and (d), making the drug unsafe under section 512(a) and adulterated under section 501(a)(