Patheon Manufacturing Services LLC – FDA 483, Aug 30, 2024

Genzyme Corporation in Ridgefield, NJ, a drug product manufacturer, received a Form 483 with four observations detailing significant deficiencies. These include inadequate production and process controls for sterile injectable products, failures in preventing microbiological contamination during aseptic processing, insufficient investigation procedures for discrepancies, and a lack of adequate oversight by the Quality Unit. The findings indicate a systemic breakdown in quality assurance and control.