Overview
- 18 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-07.
At a glance
Inspections
18
Form 483s
5
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Aug 2025 – 7 Aug 2025 | Biologics | Clean | |
| 20 Feb 2023 – 23 Feb 2023 | Biologics | Clean | |
| 19 Aug 2019 – 22 Aug 2019 | Biologics | Clean | |
| 18 Sep 2017 – 26 Sep 2017 | Biologics | Clean | |
| 2 Mar 2015 – 19 Mar 2015 | Biologics | 483 | View 483 → |
| 10 Jun 2013 – 21 Jun 2013 | Biologics | 483 | View 483 → |
| 19 Nov 2012 | Not recorded | Clean | |
| 29 Jun 2012 | Not recorded | 483 | View 483 → |
| 22 Jul 2011 | Not recorded | 483 | View 483 → |
| 11 Jun 2010 | Not recorded | Clean | |
| 30 Jul 2008 | Not recorded | Clean | |
| 26 Mar 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Mar 2015
21 CFR 600.12(a)
Maintenance - concurrence
Cited by Brandy D Brown, Leslie W Gilbert, Brandy Davis Brown
19 Mar 2015
21 CFR 606.100(b)
Maintained and followed
Cited by Brandy D Brown, Leslie W Gilbert, Brandy Davis Brown
19 Mar 2015
21 CFR 606.100(c)
Thorough investigations
Cited by Brandy D Brown, Leslie W Gilbert, Brandy Davis Brown
19 Mar 2015
21 CFR 606.165(a)
Distribution and receipt - recalls
Cited by Brandy D Brown, Leslie W Gilbert, Brandy Davis Brown
19 Mar 2015
21 CFR 606.20(b)
Qualifications of responsible personnel
Cited by Brandy D Brown, Leslie W Gilbert, Brandy Davis Brown
Investigators
FDA investigators tied to this site in the record.
Cordelia J Brammer5 insp.
Esra Toussaint4 insp.
Randy L Clarida4 insp.
Leslie W Gilbert3 insp.
Kimberly C Delk-Brooks3 insp.
Brandy D Brown2 insp.
Brandy Davis Brown2 insp.
Hristu B Chepa2 insp.
Steven D Banks1 insp.
Kenneth L Smalls1 insp.
Doretha M Tonkins1 insp.
Brentley S Collins1 insp.
Nicholas M Smith1 insp.
Jessica Fields1 insp.
Pamela L Vega1 insp.
Vincent M Williams1 insp.
Kip J Hanks1 insp.
Michelle D Haamid1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.12(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(15) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.53(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.53(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.34(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.4(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 5 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