FDA 483 - Genzyme Corporation - May 19, 2026
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Patheon Manufacturing Services LLC in Ridgefield, NJ, a vaccine manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included a failure to establish specifications for yield determination, inadequate electronic data backup for critical fill parameters, and deficient aseptic gowning procedures allowing unqualified personnel in aseptic manufacturing areas. These issues indicate serious concerns regarding quality control and the prevention of microbiological contamination for sterile drug products.
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