Genzyme Ireland Limited
Form 483 issued September 1, 2017 · Waterford, Ireland
- Inspection
- Jan 9 – Jan 17, 2025
- Investigators
- Andrea Franco· Wayne Seifert
- Observations
- 4
- Pages
- 3
- FEI number
- 3003809840
In short: On September 1, 2017, FDA issued a Form 483 with 4 observations to Genzyme Ireland Limited in Waterford, Ireland (FEI 3003809840) after an inspection that ran Jan 9 – Jan 17, 2025. The investigators were Andrea Franco and Wayne Seifert. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 3 of 4 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures, process and testing designed to prevent microbial contamination of the drug product purporting to be…
- 02
The ™® drug product manufacture…
- 03
A standard operating procedure…
- 04
Equipment used in the QC Microbiological Lab…
This inspection in context
Andrea Franco
5 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
The firmGenzyme Ireland Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genzyme Ireland Limited?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Genzyme Ireland Limited?
Andrea Franco and Wayne Seifert are named on this Form 483, for the inspection of Jan 9 – Jan 17, 2025. Each investigator has a profile showing what they cite most.
When was Genzyme Ireland Limited inspected by FDA?
The inspection ran Jan 9 – Jan 17, 2025, and the Form 483 is dated September 1, 2017.
How do I get the full Form 483 for Genzyme Ireland Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.