Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-01.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Mar 2025 – 1 Apr 2025 | Biologics | 483 | View 483 → |
| 21 May 2024 – 28 May 2024 | Human Drugs | 483 | On file |
| 17 Apr 2023 – 21 Apr 2023 | Human Drugs | Clean | |
| 30 May 2022 – 7 Jun 2022 | Biologics | 483 | View 483 → |
| 14 Nov 2019 – 22 Nov 2019 | Biologics | 483 | View 483 → |
| 16 Aug 2017 – 22 Aug 2017 | Human Drugs | 483 | On file |
| 13 Feb 2017 – 21 Feb 2017 | Human Drugs | 483 | View 483 → |
| 14 Nov 2014 – 19 Nov 2014 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Apr 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Travis S Bradley, Laurel A Beer
1 Apr 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Travis S Bradley, Laurel A Beer
1 Apr 2025
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Travis S Bradley, Laurel A Beer
7 Jun 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Gene D Arcy, Laurel A Beer
7 Jun 2022
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Gene D Arcy, Laurel A Beer
Investigators
FDA investigators tied to this site in the record.
Laurel A Beer2 insp.
Thuy T Nguyen2 insp.
Travis S Bradley1 insp.
Michael Shanks1 insp.
MRA MunizN1 insp.
Gene D Arcy1 insp.
Mihaly S Ligmond1 insp.
Junho Pak1 insp.
Donald C Obenhuber1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MSD Ireland (Carlow)'s 6 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat