# FDA 483 - Genzyme Ireland Limited - January 20, 2026

Source: https://www.keypedia.com/records/483/genzyme-ireland-limited/29309560-f75b-4125-9a74-ef7d2b0b216d

> FDA 483 for Genzyme Ireland Limited on January 20, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Genzyme Ireland Limited
- Inspection Date: 2026-01-20
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: Genzyme Ireland Limited, a drug product manufacturer in Waterford, Ireland, was inspected by the FDA. The inspection revealed significant deficiencies across multiple areas, including laboratory record keeping, data integrity, quality control procedures, facility maintenance, equipment cleaning, and investigation of discrepancies. These issues indicate a systemic failure to adhere to GMP regulations, potentially impacting product quality and safety.

## Related Documents

- [483 - 2025-01-17](https://www.keypedia.com/records/483/genzyme-ireland-limited/6a905e64-1229-4ec8-8b1d-c2219a951bff)
- [483 - 2025-01-09](https://www.keypedia.com/records/483/genzyme-ireland-limited/2ed1908d-32a8-4a30-9360-1c089b75dd21)
- [483 - 2026-01-20](https://www.keypedia.com/records/483/genzyme-ireland-limited/f536d395-67c6-4b39-969a-2301aa869975)
- [WARNING_LETTER - 2026-01-20](https://www.keypedia.com/records/warning_letter/genzyme-ireland-limited/b99411a8-8de7-4e56-90a9-83bff9e5cd4d)

## Related Officers

- [Jogy George](https://www.keypedia.com/people/jogy-george/00ef0915-66d2-4b34-9b74-d1e08caf2db3)
- [Biologist at CBER](https://www.keypedia.com/people/massoud-motamed/a8b363de-eb95-4bd3-8c05-9c34bbdbdc8a)

Company: https://www.keypedia.com/companies/genzyme-ireland-limited/ef7d4e3c-6fab-4fc3-82f7-354e88ff3aae

Office: https://www.keypedia.com/offices/fda-district-office-silver-springs-maryland/88352440-432a-426b-ad8b-f768d4460a19