FDA WARNING_LETTER - Performance Products Inc - July 20, 2012

On November 20, 2012, the FDA issued a Warning Letter to Performance Products Inc. following an inspection of their animal drug manufacturing facility in Saint Louis, Missouri, from July 16-20, 2012. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 211) for Finished Pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. § 351(a)(2)(B). Additionally, several veterinary drug products were found to be misbranded under 21 U.S.C. § 352(f) due to inadequate directions for use on their labels.

The FDA-483, issued with 8 observations, had not received a response. Key CGMP deviations included failure to provide required records (batch production, equipment cleaning, product stability testing), a recurring issue from a 2011 inspection. The firm also failed to perform identity testing for drug product components, a recurring observation since 2003. There was no written stability program for any products, and production and process control procedures were still in draft form. Furthermore, there was no cleaning validation for equipment, and scales used in manufacturing were past their calibration expiration dates.

The misbranding violations specifically cited Biozide Gel Wound Dressing and other products for failing to identify the target species. The FDA requested prompt corrective action