Regeneron Ireland Designated Activity Company Raheen Business Park
Form 483 issued March 14, 2023 · Limerick, Ireland
- Inspection
- Mar 6 – Mar 14, 2023
- Investigator
- Justin A. Boyd
- Observations
- 1
- Pages
- 8
- FEI number
- 3011684330
In short: On March 14, 2023, FDA issued a Form 483 with 1 observation to Regeneron Ireland Designated Activity Company Raheen Business Park in Limerick, Ireland (FEI 3011684330) after an inspection that ran Mar 6 – Mar 14, 2023. The investigator was Justin A. Boyd. Most observations concern quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.180 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality unit did not ensure issuance of documents is controlled and original records are maintained…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmRegeneron Ireland Designated Activity Company Raheen Business Park history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Regeneron Ireland Designated Activity Company Raheen Business Park?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Regeneron Ireland Designated Activity Company Raheen Business Park?
Justin A. Boyd is named on this Form 483, for the inspection of Mar 6 – Mar 14, 2023. Each investigator has a profile showing what they cite most.
When was Regeneron Ireland Designated Activity Company Raheen Business Park inspected by FDA?
The inspection ran Mar 6 – Mar 14, 2023, and the Form 483 is dated March 14, 2023.
How do I get the full Form 483 for Regeneron Ireland Designated Activity Company Raheen Business Park?
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