FDA 483 - Pfizer, Inc. - February 24, 2012

Pfizer Laboratories, Div. Pfizer Inc. in Groton, CT, was inspected and cited for deficiencies related to equipment cleaning and maintenance procedures. Specifically, the firm failed to establish adequate written procedures for stability chamber qualification, maintenance, and impact assessments following equipment failures. These issues indicate a lack of control over critical environmental conditions for drug product stability testing.