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Sanofi's Genzyme Corporation facility in Framingham, MA manufactured adulterated active pharmaceutical ingredients (APIs) due to significant Current Good Manufacturing Practice (CGMP) violations identified during an FDA inspection from June to July 2024. The company failed to adequately investigate critical deviations despite a concerning 20% rejection rate for bioreactor runs between January 2022 and July 2024, including multiple instances of out-of-specification lots with contamination and in-process high-pressure events that were not properly root-caused or documented. Specific failures included inadequate investigation of particle contamination in multiple product lots and product leakage during bulk transfer operations, with investigations that overlooked contradictory engineering study conclusions and incomplete documentation of investigational activities.