Capco Custom Packaging Inc – FDA Warning Letter, May 18, 2012

The FDA inspected Capco Custom Packaging Inc. from May 4-18, 2012, identifying significant CGMP violations for dietary supplements (21 CFR Part 111) and finished pharmaceuticals (21 CFR Parts 210 and 211), rendering products adulterated. Dietary supplement deficiencies included inadequate laboratory controls for reference standards (21 CFR 111.315(d), 111.35(b)(3)(iii)), failure to meet contamination specifications (21 CFR 111.73), incomplete batch records (21 CFR 111.255(b), 111.260), deficient master manufacturing records (21 CFR 111.205), and failure to qualify component suppliers (21 CFR 111.75(a)(2)(ii)(A)). Drug product violations involved inadequate OOS investigations (21 CFR 211.192), insufficient laboratory controls and testing (21 CFR 211.160(b), 211.160(a)), lack of a stability testing program (21 CFR 211.166(a)), unverified supplier analyses (21 CFR 211.84(d)(2)), inadequate process control (21 CFR 211.110(a)), and neglected annual product reviews (21 CFR 211.180(e)). The firm's responses were inadequate, lacking evidence of implemented corrective actions. Additionally, dietary supplement expiration dates were unsupported. Capco must correct violations promptly, respond within fifteen working days, and faces potential legal action and re-inspection fees.