FDA Inspection
Genzyme Ireland LimitedGenzyme Ireland Limited – FDA Inspection, Sep 2, 2015
Record Details
This FDA Inspection record concerns Genzyme Ireland Limited, with an inspection on September 2, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Genzyme Ireland Limited
- Inspection Date
- September 2, 2015
- Product Type
- Biologics
View Company Profile
ID · 6aa879fc-df01-4536-a74d-91ae43f9ecc9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 944237
- FDA center
- Biologics
- Project area
- Blood and Blood Products
Other FDA inspections of Genzyme Ireland Limited
11| Date | Classification | Office | Project area |
|---|---|---|---|
| January 20, 2026 | Not classified | Office of Inspections and Investigations | |
| January 17, 2025 | Not classified | Office of Inspections and Investigations | |
| February 25, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 5, 2018 | Not classified | Office of Inspections and Investigations | |
| February 16, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Genzyme Ireland Limited
- FDA Inspection 1301880 - 2026-01-20
- FDA Inspection 1260340 - 2025-01-17
- FDA Inspection 1174738 - 2022-02-25
- FDA Inspection 1074857 - 2018-12-05
- FDA Inspection 1050839 - 2018-02-16
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