Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-07-10.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Jul 2015 – 10 Jul 2015 | Human Drugs | 483 | View 483 → |
| 6 Jun 2015 – 10 Jun 2015 | Human Drugs | 483 | On file |
| 27 Jan 2012 | Not recorded | 483 | View 483 → |
| 27 Jan 2011 | Not recorded | Clean | |
| 19 Apr 2010 | Not recorded | 483 | View 483 → |
| 7 Nov 2008 | Not recorded | Clean | |
| 23 Jul 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Jul 2015
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Adam R Cooke, Reba A Gates, Tamara J Henderson
10 Jul 2015
21 CFR 211.198(b)(2)
Written record of complaint to include findings, follow-up
Cited by Adam R Cooke, Reba A Gates, Tamara J Henderson
10 Jul 2015
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Adam R Cooke, Reba A Gates, Tamara J Henderson
10 Jul 2015
21 CFR 211.56(b)
Written sanitation procedures not followed
Cited by Adam R Cooke, Reba A Gates, Tamara J Henderson
Investigators
FDA investigators tied to this site in the record.
Adam R Cooke2 insp.
Reba A Gates2 insp.
Tamara J Henderson2 insp.
Jason F Chancey2 insp.
Viviana Matta1 insp.
Ibad U Khan1 insp.
Jawaid Hamid1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.34 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GlaxoSmithKline LLC's 4 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