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# 2 Items on Genzyme Ireland FDA-483
- URL: https://www.fdaweb.com/2-items-on-genzyme-ireland-fda-483/
- Published: 2025-09-23T12:00:00.000Z
- Updated: 2026-09-14T15:22:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159918

FDA has released the form FDA-483 issued following a 1/9-1/17 inspection at the Genzyme Ireland drug manufacturing facility in Waterford, Ireland. The two inspection observations were:

- failure to establish procedures, processes, and testing designed to prevent microbial contamination of the drug product purporting to be sterile; and
- failure to adequately maintain redacted systems in support of drug manufacture.