FDA WARNING_LETTER - Triple C Cattle Company LLC - March 31, 2008

An FDA inspection of Triple C Cattle Company LLC's culled calf feedlot on March 26 and 31, 2008, revealed significant violations. A heifer sold for slaughter on January 17, 2008, contained 0.22 ppm of penicillin in its liver, exceeding the 0.05 ppm tolerance, rendering the animal adulterated under 21 U.S.C. §342(a)(2)(C)(ii).

The inspection also found the company lacked an adequate system to ensure medicated animals were withheld from slaughter for sufficient withdrawal periods, leading to adulterated food under 21 U.S.C. §342(a)(4). Specifically, Pro-Pen-G Injection (Penicillin G Procaine Injectable Suspension) (NADA 065-505) was routinely administered without following approved dosage levels and without the supervision of a licensed veterinarian within a valid veterinarian/client/patient relationship. This constituted extralabel drug use not in compliance with 21 C.F.R. Part 530, violating 21 C.F.R. 530.11(a) and resulting in illegal drug residues, a violation of 21 C.F.R. 530.11(d). Consequently, the drug was unsafe under 21 U.S.C. §