Overview
- 12 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-16.
At a glance
Inspections
12
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Mar 2023 – 16 Mar 2023 | Human Drugs | 483 | On file |
| 6 Feb 2023 – 10 Feb 2023 | Human Drugs | Clean | |
| 9 Sep 2019 – 17 Sep 2019 | Human Drugs | 483 | View 483 → |
| 26 Jun 2017 – 4 Jul 2017 | Human Drugs | 483 | On file |
| 22 May 2017 – 2 Jun 2017 | Human Drugs | 483 | On file |
| 15 Jun 2015 – 23 Jun 2015 | Human Drugs | 483 | View 483 → |
| 29 Apr 2013 – 9 May 2013 | Human Drugs | 483 | On file |
| 22 Sep 2011 | Not recorded | 483 | On file |
| 1 Nov 2010 | Not recorded | 483 | View 483 → |
| 3 May 2005 | Not recorded | Clean | |
| 19 Oct 2001 | Not recorded | Clean | |
| 21 May 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Sep 2019
21 CFR 211.186(b)(7)
Theoretical yield statement including percentages
Cited by Kumar G Janoria, Maya M Davis
17 Sep 2019
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Kumar G Janoria, Maya M Davis
17 Sep 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Kumar G Janoria, Maya M Davis
Investigators
FDA investigators tied to this site in the record.
Parul M Patel2 insp.
Thuy T Nguyen1 insp.
Melissa D Ray1 insp.
MRA MunizN1 insp.
Kumar G Janoria1 insp.
Maya M Davis1 insp.
Wayne E Seifert1 insp.
Zachary A Bogorad1 insp.
Samantha J Bradley1 insp.
Margaret M Annes1 insp.
Philip F Istafanos1 insp.
Kham Phommachanh1 insp.
Mihaly S Ligmond1 insp.
Bruce H Mccullough1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Glaxo Operations UK 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