No 483 issued in Genzyme follow-up inspection for ADEs.(HUMAN AND ANIMAL DRUGS)

Genzyme Corporation, Cambridge, MA New England District

During their inspection conducted July 24-25, 2007, FDA investigators Debra Emerson and Megan Haggerty found that Genzyme Corporation had made the promised corrective actions to its systems and procedures for reporting serious and unexpected adverse drug events (SADEs) since the agency issued a 483 after its Oct. 11-19, 2006, inspection.

The investigators wrote in the EIR, "The firm has implemented revised procedures and trained personnel as promised in their response to their FDA inspection in 2006." The drug manufacturer developed an AE Education training module that all employees and contractors must complete. In addition, specific training programs were also developed for and delivered to medical information staff, pharmacovigilance staff, data entry personnel and employees at distribution sites on patient safety issues, pharmacovigilance and preparation of SADE reports.

Although Genzyme had 38 late reports since Nov. 1, 2006, the FDAers observed that "this was expected as the firm reviewed all of their SADE reports and found additional late submissions" after the previous inspection.

The firm had also developed and implemented a call system for product recalls that requires Genzyme staff to respond to possible product problems at any time, the inspectors stated. Genzyme also revised several key policies as it had committed to do after the 2006 inspection, including procedures on Global Product Event Management; Intake and Reporting of Safety Information of Products; Management of Drug, Biologic and Device Safety Information; and submission of annual reports.

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