Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-08.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 May 2026 – 8 May 2026 | Biologics | 483 | View 483 → |
| 24 Oct 2019 – 1 Nov 2019 | Medical Devices & Rad Health | Clean | |
| 8 May 2017 – 12 May 2017 | Medical Devices & Rad Health | Clean | |
| 26 Jan 2012 | Not recorded | 483 | View 483 → |
| 2 Feb 2010 | Not recorded | WL | View 483 → |
| 19 Aug 2005 | Not recorded | Clean | |
| 19 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 May 2026
21 CFR 56.115(a)(2)
Minutes of IRB meetings
Cited by Andrace Deyampert, Victoria R Flournoy, Stephen O Agyemang
26 Jan 2012
21 CFR 56.110(b)(2)
Minor changes
Cited by Neali H Lucas, L'Oreal F Walker, Nancy A Bellamy
2 Feb 2010
21 CFR 56.107(d)
One non-affiliate member
Cited by Sherri J Jackson, Nancy A Bellamy, Laureen F Kononen
2 Feb 2010
21 CFR 56.107(f)
Invited individual allowed to vote with IRB
Cited by Sherri J Jackson, Nancy A Bellamy, Laureen F Kononen
2 Feb 2010
21 CFR 56.108(c)
Members present for review
Cited by Sherri J Jackson, Nancy A Bellamy, Laureen F Kononen
Investigators
FDA investigators tied to this site in the record.
Andrace Deyampert2 insp.
Neali H Lucas2 insp.
Nancy A Bellamy2 insp.
Victoria R Flournoy1 insp.
Stephen O Agyemang1 insp.
Corrine M Carter1 insp.
L'Oreal F Walker1 insp.
Sherri J Jackson1 insp.
Laureen F Kononen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.115(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 56.107(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.107(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.110(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site'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