FDA EIR - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - November 26, 2019

An FDA inspection of Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Sanford, NC, conducted from November 19-26, 2019, identified significant deficiencies, many recurring from a previous April 2018 inspection. The facility, a bulk vaccine manufacturer for Prevenar 13, was evaluated under Compliance Program C.P. 7345.848 for Biological Drug Products. Key violations, outlined in a seven-item FDA Form 483, centered on inadequate control and oversight of Master and Working Cell Banks (MCB/WCB). Issues included improper storage arrangements, not meeting regulatory requirements like 21 CFR 610.18, and insufficient accountability within the GMP inventory database. There was a critical lack of Quality Assurance oversight for off-site storage service providers, specifically concerning cell bank destruction and relocation without proper review or approval. The inspection also highlighted systemic data integrity problems, with incomplete responses to previous data accuracy concerns and insecure backup data. Deviations were frequently incomplete, lacked documentation, and were not adequately assessed for product quality impact, exemplified by an uninvestigated media transfer line leak and unidentified particulates in product without supporting safety data. Furthermore, initial Out of Specification results were not consistently investigated at the manufacturing level. Management committed to providing a written response to the FDA within 15 business days.