FDA 483 - Pfizer Italia S.r.l.

Pfizer Italia, SRL in Ascoli Piceno, Italy, a finished drug product facility, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate cleaning validation, failures in quality assurance procedures for drug product identity and purity, an insufficient stability program, and a lack of detailed written procedures for component sampling and storage. These issues indicate a need for improved controls over manufacturing processes and quality systems.