FDA WARNING_LETTER - Virbac Inc. - July 29, 2008

On July 21-29, 2008, an FDA inspection of Virbac, Inc. in Bridgeton, Missouri, revealed numerous violations of current Good Manufacturing Practice (cGMP) regulations (21 CFR Parts 210 and 211), rendering drug products adulterated. Repeat violations from a July 2007 inspection were noted.

Key cGMP violations include: 1. **Quality Control Unit Deficiencies (21 CFR 211.22(a)):** Failure of the Quality Assurance unit to be informed of and investigate temperature excursions in refrigerated storage and stability chambers. 2. **Failure to Follow SOPs (21 CFR 211.100(b)):** Non-adherence to Warehouse Standard Operating Procedure #0211-034 regarding drug product handling. 3. **Failure to Follow Production Procedures (21 CFR 211.110):** Non-compliance with Receiving Warehouse SOP #0211-034, specifically regarding documentation and QA review of temperature excursions. 4. **Inadequate Laboratory Controls (21 CFR 211.160(b)):** HPLC methods for Praziquantel and Ivermectin analysis lacked clear interpretation of impurity peaks, sample preparation specifics, placebo instructions, and consistent comparisons. 5. **Failure to Calibrate Instruments (21 CFR