MSD Ireland (Carlow)
Form 483 issued November 22, 2019 · Carlow, Ireland
- Inspection
- Nov 14 – Nov 22, 2019
- Investigator
- Mihaly S. Ligmond
- Observations
- 2
- Pages
- 3
- FEI number
- 3008694906
In short: On November 22, 2019, FDA issued a Form 483 with 2 observations to MSD Ireland (Carlow) in Carlow, Ireland (FEI 3008694906) after an inspection that ran Nov 14 – Nov 22, 2019. The investigator was Mihaly S. Ligmond. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling ans designed to…
This inspection in context
Mihaly S. Ligmond
20 documents · 2006–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
The firmMSD Ireland (Carlow) history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MSD Ireland (Carlow)?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected MSD Ireland (Carlow)?
Mihaly S. Ligmond is named on this Form 483, for the inspection of Nov 14 – Nov 22, 2019. Each investigator has a profile showing what they cite most.
When was MSD Ireland (Carlow) inspected by FDA?
The inspection ran Nov 14 – Nov 22, 2019, and the Form 483 is dated November 22, 2019.
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.