Regeneron Ireland Designated Activity Company Raheen Business Park
FDA inspection history across 2 sites, 2021 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Two Form 483s, at LIMERICK, Ireland and Limerick, Ireland.
- 2023The longest 483 on file: 1 observation over 8 pages at Limerick, Ireland.
Cited most
Across all Regeneron Ireland Designated Activity Company Raheen Business Park observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.180General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Regeneron Ireland Designated Activity Company Raheen Business Park file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Limerick, Ireland
One Form 483 · 2023 · 1 observation
Latest: Form 483, Mar 14, 2023 →LIMERICK, Ireland
One Form 483 · 2021
Latest: Form 483, May 7, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-14 | 483 Form 483 | Limerick, Ireland | 1 | $99 |
| 2021-05-07 | 483 Form 483 | LIMERICK, Ireland | — | $99 |
Investigators on these documents
FEI number 3011684330 · most recent document Mar 14, 2023
About Regeneron Ireland Designated Activity Company Raheen Business Park
How many FDA Form 483s has Regeneron Ireland Designated Activity Company Raheen Business Park received?
FDA Intel has 2 Form 483s on file for Regeneron Ireland Designated Activity Company Raheen Business Park; the most recent is dated Mar 14, 2023.
When was Regeneron Ireland Designated Activity Company Raheen Business Park last inspected by FDA?
The most recent FDA inspection document on file for Regeneron Ireland Designated Activity Company Raheen Business Park is a Form 483 dated Mar 14, 2023, for the site in Limerick, Ireland.
What did FDA cite at Regeneron Ireland Designated Activity Company Raheen Business Park?
The regulations cited most in the observations on file for Regeneron Ireland Designated Activity Company Raheen Business Park are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.180 (General requirements), 1 time.