FDA 483 - Resilience Boston Inc. - October 10, 2008

An FDA inspection of Genzyme Corporation's facility in Allston, MA, conducted from September 15 to October 10, 2008, revealed significant deviations from Current Good Manufacturing Practices (cGMP). The observations highlighted critical issues in manufacturing processes and quality systems. Key violations included inadequate bioburden monitoring during drug purification and buffer control, along with substantial deficiencies in batch production record documentation, such as uncontrolled manufacturing records and incomplete activity logging. The inspection also identified unauthorized manufacturing activities lacking proper documentation, and shortcomings in HVAC system qualification and aseptic filling line validation for current operational speeds. Further issues involved inadequate personnel monitoring procedures, insufficient maintenance of critical equipment like chromatography columns and cryoshippers, and quality assurance approval of a validation report that failed to meet its protocol requirements. Cleaning validation assessments were deemed inadequate, and the company did not consistently adhere to its document control procedures. Additionally, incomplete deviation files, an incorrect specific gravity entry in an automated buffer formulation system, and major deficiencies in master production and control records (missing crucial details for drug product and substance) were cited. Genzyme Corporation is expected to promptly address these observations to ensure full compliance with federal regulations for drug manufacturing.