FDA WARNING_LETTER - Warner Chilcott Company, LLC - July 29, 2011

An FDA inspection conducted from June 22 to July 29, 2011, at Warner Chilcott Company, LLC in Fajardo, Puerto Rico, identified significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering drug products adulterated. The firm's August 18, 2011 response was deemed insufficient. Key violations include the failure to thoroughly investigate batch failures to meet specifications (21 CFR § 211.192), specifically for Ovcon 50 tablets, where 7 of 9 stability lots failed the Ethinyl Estradiol assay since 2006, without identifying a root cause or implementing effective corrective actions, leading to the continued release of potentially subpotent batches. Additionally, the quality control unit failed to fulfill its responsibilities (21 CFR § 211.22(a)) by not assuring product quality throughout its shelf life, incorrectly attributing stability failures to analytical method robustness, and failing to evaluate relevant developmental and technical transfer data. The firm is required to provide details on packaging process changes, stability data, and contact CDER for NDA modifications. They must also demonstrate changes to their quality system, ensure personnel understanding and qualifications, and conduct a comprehensive retrospective review of their stability program for all products. Failure to promptly correct these violations may result in legal action, including seizure and injunction, and impact export certificates or pending drug applications.