MSD Ireland (Carlow)
Form 483 issued June 7, 2022 · Carlow, Ireland
- Inspection
- May 30 – Jun 7, 2022
- Observations
- 2
- Pages
- 3
- FEI number
- 3008694906
In short: On June 7, 2022, FDA issued a Form 483 with 2 observations to MSD Ireland (Carlow) in Carlow, Ireland (FEI 3008694906) after an inspection that ran May 30 – Jun 7, 2022. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.42(c)(10)(iv) (1×) · 211.110(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Control procedures are not established which monitor the output of those manufacturing processes that may be…
This inspection in context
Questions about this 483
What did FDA find at MSD Ireland (Carlow)?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was MSD Ireland (Carlow) inspected by FDA?
The inspection ran May 30 – Jun 7, 2022, and the Form 483 is dated June 7, 2022.
How do I get the full Form 483 for MSD Ireland (Carlow)?
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.