FDA 483 - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - January 17, 2019

Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC in Andover, MA, was inspected and cited for deficiencies in laboratory control mechanisms. Observations included a failure to properly establish and follow procedures for evaluating invalid GMP assays and investigating multiple assay failures, as well as inadequate documentation of instrument checks and maintenance for a spectrophotometer used in testing. These issues indicate a lack of robust quality control and data integrity practices.