Overview
- 12 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-03-13.
At a glance
Inspections
12
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Mar 2018 – 13 Mar 2018 | Human Drugs | Clean | |
| 30 May 2017 – 6 Jun 2017 | Human Drugs | Clean | |
| 28 Nov 2016 – 6 Dec 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Apr 2015 – 8 May 2015 | Human Drugs | 483 | View 483 → |
| 4 Sep 2014 – 12 Sep 2014 | Human Drugs | 483 | View 483 → |
| 20 Jul 2012 | Not recorded | 483 | View 483 → |
| 24 Jun 2009 | Not recorded | 483 | View 483 → |
| 9 Dec 2008 | Not recorded | 483 | On file |
| 9 Nov 2007 | Not recorded | Clean | |
| 24 May 2007 | Not recorded | Clean | |
| 22 Apr 2005 | Not recorded | Clean | |
| 4 Apr 2003 | 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.
Marcus F Yambot2 insp.
Russell J Glapion1 insp.
Roger F Zabinski1 insp.
Clotia C Abbey Mensah1 insp.
Carla A Norris1 insp.
Karen E Dorazio1 insp.
Susan T Hadman1 insp.
Bruce H Mccullough1 insp.
Matthew B Casale1 insp.
Steven B Hertz1 insp.
Simone E Pitts1 insp.
Susan M Jackson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | 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 211.94(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Patheon UK Limited's 6 Form 483s
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