pm resources, inc. – FDA Warning Letter, Dec 30, 2014

An FDA inspection of Virbac Animal Health, Inc. in Bridgeton, Missouri, from October 29 to December 30, 2014, revealed significant deviations from cGMP regulations (21 CFR Part 211), rendering their animal drugs adulterated. Many observations were repeat violations from prior inspections (2007, 2008, 2010, 2013).

Key violations included: 1. **Failure to establish and adequately staff a quality control unit (21 CFR 211.22)**: The Quality Unit failed to prevent release of out-of-specification (OOS) products, conduct thorough investigations, extend investigations to other affected products, use change control, and ensure regulatory submissions. 2. **Failure to reject drug products failing specifications (21 CFR 211.165(f))**: The firm repeatedly re-tested or re-sampled OOS products without scientific rationale until passing results were obtained, then reported only passing or averaged results. 3. **Failure to validate manufacturing processes (21 CFR 211.110(a))**: Specific processes for several products, including Iverhart Max® and Iverhart Plus®, were not validated, and a water system performance qualification failed without proper investigation. 4. **Failure to follow written procedures for drug product storage (21 CFR 21