Overview
- 11 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-11-16.
At a glance
Inspections
11
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Oct 2017 – 16 Nov 2017 | Human Drugs | 483 | On file |
| 1 Feb 2016 – 5 Feb 2016 | Human Drugs | 483 | View 483 → |
| 9 Mar 2015 – 13 Mar 2015 | Human Drugs | 483 | View 483 → |
| 8 Sep 2014 – 12 Sep 2014 | Human Drugs | 483 | View 483 → |
| 12 Aug 2013 – 15 Aug 2013 | Human Drugs | WL | View 483 → |
| 29 Aug 2012 | Not recorded | 483 | On file |
| 10 Jun 2011 | Not recorded | 483 | On file |
| 1 Jul 2009 | Not recorded | 483 | View 483 → |
| 20 Jul 2006 | Not recorded | Clean | |
| 23 Aug 2005 | Not recorded | Clean | |
| 4 Oct 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Feb 2016
21 CFR 211.165(a)
Testing and release for distribution
Cited by Shayla G Turnipseed, Laura L Staples
5 Feb 2016
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Shayla G Turnipseed, Laura L Staples
5 Feb 2016
21 CFR 211.166(a)
Written program not followed
Cited by Shayla G Turnipseed, Laura L Staples
Investigators
FDA investigators tied to this site in the record.
Laura L Staples3 insp.
Marvin D Jones2 insp.
Shayla G Turnipseed1 insp.
Zada L Giles1 insp.
Erica M Katherine1 insp.
Samantha J Bradley1 insp.
Francis A Guidry1 insp.
Marcus L Head1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.34 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Keystone Laboratories, Inc.'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