FDA EIR - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - January 18, 2019

The FDA conducted a pre-license inspection of Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC (Pfizer Andover) in Andover, MA, from January 14-18, 2019. The inspection focused on drug substance manufacturing for a proposed biosimilar, adhering to regulatory frameworks such as CP 7356.002M, CP 7346.832, and ICH Q7. A Form FDA-483 was issued, highlighting a main violation: critical materials and reagents used for release and stability testing of drug substance and drug product were not adequately controlled. Inspectors also noted concerns about potential inconsistencies in laboratory sample results due to insufficient procedural detail for manual peak integration in the QC Chemistry Laboratory, prompting an open Corrective and Preventive Action (CAPA). The inspection, which covered Quality, Facility and Equipment, Materials, Production, and Laboratory Control systems, resulted in a "Voluntary Action Indicated" (VAI) classification. This classification requires Wyeth BioPharma to implement voluntary corrective measures to address the identified deficiencies, specifically improving material control and ensuring analytical method consistency.