Overview
- 13 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-03.
At a glance
Inspections
13
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2023 – 3 Mar 2023 | Human Drugs | 483 | View 483 → |
| 27 Feb 2023 – 2 Mar 2023 | Medical Devices & Rad Health | Clean | |
| 3 Jun 2019 – 7 Jun 2019 | Human Drugs | Clean | |
| 28 Nov 2016 – 6 Dec 2016 | Human Drugs | 483 | On file |
| 21 Mar 2016 – 24 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Nov 2014 – 7 Nov 2014 | Human Drugs | 483 | On file |
| 4 Apr 2012 | Not recorded | 483 | On file |
| 31 Aug 2011 | Not recorded | 483 | View 483 → |
| 30 Jun 2009 | Not recorded | 483 | On file |
| 23 Oct 2008 | Not recorded | 483 | On file |
| 25 May 2007 | Not recorded | Clean | |
| 13 Jun 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Mar 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Truong X Nguyen, Michele Gottshall
3 Mar 2023
21 CFR 211.110(b)
In-process specification, invalid
Cited by Truong X Nguyen, Michele Gottshall
3 Mar 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Truong X Nguyen, Michele Gottshall
3 Mar 2023
21 CFR 211.160(b)(1)
Determination of conformance
Cited by Truong X Nguyen, Michele Gottshall
Investigators
FDA investigators tied to this site in the record.
Christopher T Middendorf2 insp.
Truong X Nguyen1 insp.
Michele Gottshall1 insp.
Dawn M Braswell1 insp.
Susan O Oladeji1 insp.
Tracy K Li1 insp.
Catherine J Laufmann1 insp.
Omotunde O Osunsanmi1 insp.
Erin D Mccaffery1 insp.
Mei-Chiung J Huang1 insp.
Regina T Brown1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(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 BWXT Medical Ltd.'s 8 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