FDA 483 - Pfizer Ireland Pharmaceuticals Unlimited Company - September 10, 2018

Pfizer Ireland Pharmaceuticals, a drug manufacturer in Clondalkin, Ireland, received a Form 483 citing several significant deficiencies during an FDA inspection. Observations included inadequate investigation records for unexplained discrepancies, insufficient review of atypical test results, ambiguous adverse event reporting, and deficiencies in environmental monitoring and laboratory controls. These issues indicate a need for improved quality system oversight and adherence to GMP requirements.