Overview
- 11 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-02-19.
At a glance
Inspections
11
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Feb 2025 | Biologics | Clean | |
| 10 May 2023 | Biologics | 483 | View 483 → |
| 20 May 2019 | Biologics | Clean | |
| 5 Jul 2017 | Biologics | Clean | |
| 13 Jul 2015 | Biologics | Clean | |
| 19 Jul 2013 | Biologics | Clean | |
| 31 Oct 2011 | Not recorded | Clean | |
| 19 Nov 2009 | Not recorded | Clean | |
| 19 Feb 2008 | Not recorded | Clean | |
| 27 Mar 2002 | Not recorded | Clean | |
| 14 Feb 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 May 2023
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Barbara T Carmichael
Investigators
FDA investigators tied to this site in the record.
Barbara T Carmichael4 insp.
Ronnie E Jackson2 insp.
Steen N Graham1 insp.
Lura D Baquero1 insp.
Stacey F Rivette1 insp.
Ashley B Jelonek1 insp.
Lindsay R Hatch1 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 | 1x |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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