FDA WARNING_LETTER - Clearview Farms - January 13, 2010

On January 11 and 13, 2010, the FDA inspected Clearview Farms, identifying violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on August 19, 2009, was found to have neomycin in its kidney at 7.34 ppm, exceeding the 7.2 ppm tolerance, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The farm also held animals under insanitary conditions, likely allowing medicated animals with harmful drug residues into the food supply, specifically due to a failure to maintain complete treatment records, which adulterates food under 21 U.S.C. 342(a)(4).

Furthermore, the drug Draxxin (Tulathromycin) Injectable Solution was used in an extralabel manner on a bull calf without following approved labeling or veterinarian supervision, violating 21 C.F.R. Part 530 and rendering the drug unsafe under 21 U.S.C. 360b(a)(4) and adulterated under 21 U.S.C. 351(a)(5).

Clearview Farms must take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions and timelines is required within fifteen working days to the