FDA 483 - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC

An FDA inspection of Wyeth BioPharma Division in Andover, MA, identified deficiencies in the control of critical materials and reagents. The firm failed to adequately monitor the handling of reference materials and lacked sufficient procedures for the qualification of new lots of critical bioassay reagents. These issues indicate a need for improved quality control systems for testing materials used in drug substance and drug product manufacturing.