Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-03-18.
At a glance
Inspections
6
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Mar 2016 – 18 Mar 2016 | Human Drugs | 483 | View 483 → |
| 1 Aug 2013 – 23 Aug 2013 | Human Drugs | 483 | On file |
| 19 Aug 2013 – 21 Aug 2013 | Human Drugs | Clean | |
| 7 Sep 2010 | Not recorded | Clean | |
| 15 Jul 2010 | Not recorded | 483 | On file |
| 10 May 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Mar 2016
21 CFR 58.35(b)(5)
QAU: authorize deviations from protocols or SOPs
Cited by Mark J Seaton, Marcelo O Mangalindan, Ching-Jey G Chang, Tahseen Mirza
Investigators
FDA investigators tied to this site in the record.
Marcelo O Mangalindan3 insp.
Mark J Seaton1 insp.
Ching-Jey G Chang1 insp.
Tahseen Mirza1 insp.
Mike M Rashti1 insp.
Kristina J Donohue1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GlaxoSmithKline LLC's 3 Form 483s
Source PDFs 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