FDA 483 - Pfizer Italia S.r.l. - June 29, 2018

An FDA inspection of Pfizer Italia, SRL, conducted from June 25-29, 2018, identified multiple deficiencies related to Good Manufacturing Practices for finished drug products. Key observations included inadequate control procedures for manufacturing processes, specifically regarding cleaning validations. The cleaning matrix was found deficient in selecting worst-case products, and cleaning procedures lacked proper documentation for detergent usage and hold times. Furthermore, cleaning validation for campaign manufacturing failed to adequately address contaminant build-up and carry-over. The inspection also highlighted deficiencies in quality assurance procedures designed to ensure drug product identity, strength, quality, and purity. Issues included a failure to demonstrate system suitability in analytical testing, inadequate sample preparation for impurity methods that could lead to missing impurities, and a lack of retention for observed defects during visual inspection of empty capsules. Microbial testing also showed a lack of assurance regarding media temperature control. Additional observations involved a deficient written stability program for certain capsules, lacking proven stability-indicating test methods. Lastly, the firm lacked comprehensive written procedures for the sampling and storage of components, particularly regarding supplier-provided pre-samples and the periodic evaluation of the automated warehouse. Pfizer Italia, SRL, is expected to address these observations with robust corrective and preventive actions to ensure compliance with regulatory standards.