Regeneron Ireland Designated Activity Company Raheen Business Park
Form 483 issued May 7, 2021 · LIMERICK, Ireland
- Inspection
- May 4 – May 7, 2021
- Observations
- 4
- Pages
- 2
- FEI number
- 3011684330
In short: On May 7, 2021, FDA issued a Form 483 with 4 observations to Regeneron Ireland Designated Activity Company Raheen Business Park in LIMERICK, Ireland (FEI 3011684330) after an inspection that ran May 4 – May 7, 2021. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You failed to establish engineering controls for your electronic data acquisition systems to ensure protection of…
- 02
Personnel engaged in the manufacturing are not adequately trained in the particular operations they perform and/or…
- 03
The microbial ingress risk during drug substance manufacturing is not adequately controlled due to recurring in-process…
- 04
Investigation of HEPA filter failures and, corrective and preventive actions intended to resolve to HEPA filter…
This inspection in context
Questions about this 483
What did FDA find at Regeneron Ireland Designated Activity Company Raheen Business Park?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Regeneron Ireland Designated Activity Company Raheen Business Park inspected by FDA?
The inspection ran May 4 – May 7, 2021, and the Form 483 is dated May 7, 2021.
How do I get the full Form 483 for Regeneron Ireland Designated Activity Company Raheen Business Park?
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.