FDA WARNING_LETTER - Provident Pharmaceuticals LLC - June 19, 2009

An FDA inspection of Provident Pharmaceuticals, LLC, from June 1-19, 2009, revealed significant Current Good Manufacturing Practice (CGMP) violations (21 CFR 210 and 211), rendering drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm also manufactures unapproved new prescription drugs, violating 21 U.S.C. §§ 331(d) and 355(a), and these drugs are misbranded per 21 U.S.C. § 352(f)(1), violating 21 U.S.C. § 331(a).

Key CGMP violations include the Quality Control Unit's (QCU) failure to: establish valid test methods, ensure stability samples are tested on schedule, conduct annual product reviews, thoroughly investigate Out-of-Specification (OOS) results, and perform internal audits of corrective actions. Test methods for components and drug products were not validated, violating 21 CFR 211.165(e). The firm failed to conduct annual product reviews (21 CFR 211.180(e)) and thoroughly investigate OOS results (21 CFR 211.192), including invalidating confirmed OOS results without justification. The stability testing program was not followed,