# Genzyme Ireland Limited, Waterford, Ireland – FDA Inspections

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

> Inspection records and compliance data for Genzyme Ireland Limited in Waterford. 12 FDA inspections on record, 3 Form 483s, 1 warning letter, last inspected January 20, 2026.

---

## Details

- Name: Genzyme Ireland Limited
- FEI Number: 3003809840
- Address Line 1: Unit 701, Ida Industrial Par; Old Kilmeaden Road
- City: Waterford
- Country Name: Ireland
- Address: Unit 701, Ida Industrial Par; Old Kilmeaden Road, Waterford, Ireland
- Country: Ireland

## Related Documents

- [483 - Genzyme Ireland Limited - 2026-01-20](https://www.keypedia.com/records/483/genzyme-ireland-limited/f536d395-67c6-4b39-969a-2301aa869975) — source: FDA, date: January 20, 2026
- [WARNING_LETTER - Genzyme Ireland Limited - 2026-01-20](https://www.keypedia.com/records/warning_letter/genzyme-ireland-limited/b99411a8-8de7-4e56-90a9-83bff9e5cd4d) — source: FDA, date: January 20, 2026
- [FDA Inspection 1301880 - Genzyme Ireland Limited - 2026-01-20](https://www.keypedia.com/records/fda_inspections/genzyme-ireland-limited/11ca1183-4f70-4146-abc3-2ba41b06fb88) — source: FDA, date: January 20, 2026
- [FDA Inspection 1260340 - Genzyme Ireland Limited - 2025-01-17](https://www.keypedia.com/records/fda_inspections/genzyme-ireland-limited/ba9188c1-471f-4911-b37b-a4d7ce0216a8) — source: FDA, date: January 17, 2025
- [483 - Genzyme Ireland Limited - 2025-01-09](https://www.keypedia.com/records/483/genzyme-ireland-limited/2ed1908d-32a8-4a30-9360-1c089b75dd21) — source: FDA, date: January 9, 2025
- FDA Inspection 1174738 - Genzyme Ireland Limited - 2022-02-25 — classification: Voluntary Action Indicated (VAI), source: FDA, date: February 25, 2022
- FDA Inspection 1074857 - Genzyme Ireland Limited - 2018-12-05 — source: FDA, date: December 5, 2018
- [FDA Inspection 1050839 - Genzyme Ireland Limited - 2018-02-16](https://www.keypedia.com/records/fda_inspections/genzyme-ireland-limited/9e6c6396-c208-45d6-9fdc-a434c8f3b295) — classification: No Action Indicated (NAI), source: FDA, date: February 16, 2018
- FDA Inspection 1015545 - Genzyme Ireland Limited - 2017-06-16 — classification: Voluntary Action Indicated (VAI), source: FDA, date: June 16, 2017
- [FDA Inspection 1015545 - Genzyme Ireland Limited - 2017-06-16](https://www.keypedia.com/records/fda_inspections/genzyme-ireland-limited/bb8bee9a-ff21-4244-870a-ce25e68ed5da) — classification: Voluntary Action Indicated (VAI), source: FDA, date: June 16, 2017
- FDA Inspection 944237 - Genzyme Ireland Limited - 2015-09-02 — classification: Voluntary Action Indicated (VAI), source: FDA, date: September 2, 2015
- [FDA Inspection 944237 - Genzyme Ireland Limited - 2015-09-02](https://www.keypedia.com/records/fda_inspections/genzyme-ireland-limited/6aa879fc-df01-4536-a74d-91ae43f9ecc9) — classification: Voluntary Action Indicated (VAI), source: FDA, date: September 2, 2015
- [FDA Inspection 907153 - Genzyme Ireland Limited - 2013-09-26](https://www.keypedia.com/records/fda_inspections/genzyme-ireland-limited/152db5c0-acff-4196-b601-5c65cfb6f2af) — classification: Voluntary Action Indicated (VAI), source: FDA, date: September 26, 2013

## Related Companies

- [Sanofi Winthrop Industrie](https://www.keypedia.com/companies/sanofi-winthrop-industrie/c811b5aa-08fe-4a09-ae00-f302ada6f489)
- [Baxter Pharmaceutical Solutions, LLC](https://www.keypedia.com/companies/baxter-pharmaceutical-solutions-llc/dd8344ef-ad46-49b8-8b39-fb1d8cb518d8)
- [Quality Packaging Specialists International, LLC](https://www.keypedia.com/companies/quality-packaging-specialists-international-llc/74a9861b-efac-463e-b6f9-bd1e22db674a)
- [Fareva Unterach GmbH](https://www.keypedia.com/companies/fareva-unterach-gmbh/04c4438b-dd74-4814-8d9d-74a9aaba9026)
- [AndersonBrecon Inc.](https://www.keypedia.com/companies/andersonbrecon-inc/799f84ea-9114-456a-83f1-7edcd7eb4d2e)
- [Sovereign Pharmaceuticals, LLC](https://www.keypedia.com/companies/sovereign-pharmaceuticals-llc/b8432227-cad1-4c55-91cc-a8c613f765fd)
- [Lannett Company LLC](https://www.keypedia.com/companies/lannett-company-llc/d4d7f04f-0ec5-4f5a-868b-d48963202cc8)
- [The Procter & Gamble Manufacturing Company](https://www.keypedia.com/companies/the-procter-gamble-manufacturing-company/ceebac3f-c234-4225-b666-964153cdba97)
- [Frontage Laboratories, Inc.](https://www.keypedia.com/companies/frontage-laboratories-inc/1705f97d-14a3-4e46-b8a5-220bf2c4799f)
- [PTI Georgia, LLC](https://www.keypedia.com/companies/pti-georgia-llc/a1dea629-43b4-4dda-963c-1b320b0311a5)

## Related Officers

- [Pharmaceutical Scientist](https://www.keypedia.com/people/andrea-franco/96b35431-a713-48a5-9a47-e160cc650730)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)
- [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)
- [Vincent Amatrudo](https://www.keypedia.com/people/vincent-amatrudo/f8eaf620-d888-41d0-91ff-5001388a5fbe)