FDA 483 - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - April 28, 2017

An FDA inspection of Wyeth BioPharma Division in Andover, MA, a drug substance manufacturer, revealed significant issues related to aseptic processing, equipment requalification, and unapproved manufacturing changes. Observations included inadequate space for aseptic operations, failure to follow procedures for scale movement, lack of temperature mapping for old stability storage units, and an unsubmitted change in the manufacture of drug substance containers. These findings indicate potential deficiencies in the firm's quality systems and compliance with good manufacturing practices.