FDA 483 - Genzyme Corporation - July 25, 2022

An FDA inspection of Genzyme Corporation's drug substance manufacturing facility in Framingham, MA, conducted from July 18-22 and July 25, 2022, resulted in a Form FDA 483 citing significant observations regarding compliance with manufacturing regulations. The primary issues identified were failures in computerized system controls and facility maintenance.

Specifically, the company did not exercise sufficient controls over computerized systems, failing to adequately review audit trails for critical testing equipment used in Thyrogen bulk drug substance manufacturing. This led to instances where failed and canceled tests were not recorded in official manufacturing logs, impacting the integrity of data for numerous lots produced since January 2020.

Additionally, the inspection noted inadequate maintenance of the manufacturing buildings and facilities. Observations included rust in a Grade-A cleanroom, chipped floors in Grade-C manufacturing areas, and unidentified liquid puddles, floor cracks, and leaks from equipment in Grade-D rooms. These deficiencies pose risks to product quality and environmental control.

Genzyme Corporation is required to respond to the FDA with a comprehensive plan of corrective actions to address these observations and ensure adherence to regulatory standards for drug manufacturing.