Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-13.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jun 2025 – 13 Jun 2025 | Human Drugs | 483 | View 483 → |
| 12 Jun 2018 – 14 Jun 2018 | Human Drugs | Clean | |
| 2 Feb 2015 – 6 Feb 2015 | Human Drugs | Clean | |
| 18 Mar 2013 – 22 Mar 2013 | Human Drugs | 483 | View 483 → |
| 9 Mar 2010 | Not recorded | Clean | |
| 16 May 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Khoa Nathan V Tran1 insp.
MRA DavisM1 insp.
James C Maclaughlin1 insp.
Nicholas L Paulin1 insp.
Bruce H Mccullough1 insp.
Mei-Chiung J Huang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Organon Pharma (UK) Ltd.'s 2 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