Paul Bianchi, Inc. – FDA Warning Letter, Aug 31, 2012

On August 28, 29, and 31, 2012, the FDA inspected Paul Bianchi, Inc.'s dairy operation in Valley Ford, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The company adulterated new animal drugs, specifically (b)(4) (oxytetracycline hydrochloride) Injectable, (b)(4) (amoxicillin) (b)(4) (cephapirin (b)(4) for Intramammary Infusion, (b)(4) (furosemide), and (b)(4) (ceftiofur (b)(4) by using them in an extralabel manner without following approved labeling or a veterinarian's prescription, and without veterinary supervision, violating 21 C.F.R. 530.11(a).

Specific violations include administering (b)(4) (oxytetracycline hydrochloride) Injectable without following the approved animal class, (b)(4) (amoxicillin) (b)(4) without observing the slaughter withdrawal period, (b)(4) (cephapirin (b)(4) for Intramammary Infusion without adhering to dose limitations and slaughter withdrawal, (b)(4) (furosemide) without following milk and meat withhold times, and (b)(4) (ceftiofur (b)(4) without observing meat withhold times. Additionally,