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FDA To Re-inspect Genzyme Facility

The FDA will re-inspect Genzyme’s Allston Landing manufacturing facility.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA informed Genzyme that it will re-inspect the company’s Allston Landing, MA manufacturing facility. The re-inspection is a follow-up to an inspection the agency conducted in May 2009 and is intended to verify that all CAPA identified in a February warning letter have been implemented. In a letter to Genzyme, the agency indicated that all promised actions had not been either fully or adequately implemented at the time of the May inspection.During the re-inspection, the FDA will also rev...

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