Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-07-10.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jul 2015 – 10 Jul 2015 | Human Drugs | WL | On file |
| 19 Oct 2012 | Not recorded | 483 | View 483 → |
| 18 Mar 2011 | Not recorded | 483 | On file |
| 18 Sep 2008 | Not recorded | Clean | |
| 13 Jun 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Oct 2012
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Stephen D Brown, David J Gomes, Pal S Mayasandra
Investigators
FDA investigators tied to this site in the record.
Justin A Boyd1 insp.
Patricia D Stahnke1 insp.
Stephen D Brown1 insp.
David J Gomes1 insp.
Pal S Mayasandra1 insp.
Tammara A Stephens1 insp.
Brooke K Higgins1 insp.
Nancy G Schmidt1 insp.
Sixto M Mercado Rios1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SmithKline Beecham Limited's 3 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