Overview
- 10 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-25.
At a glance
Inspections
10
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Oct 2024 – 25 Oct 2024 | Biologics | Clean | |
| 13 Jun 2019 – 14 Jun 2019 | Biologics | Clean | |
| 14 Oct 2016 – 18 Oct 2016 | Biologics | Clean | |
| 24 Feb 2015 – 25 Feb 2015 | Biologics | Clean | |
| 30 Jul 2013 – 6 Aug 2013 | Biologics | 483 | View 483 → |
| 10 Feb 2011 | Not recorded | Clean | |
| 25 Jan 2010 | Not recorded | Clean | |
| 4 Feb 2009 | Not recorded | 483 | View 483 → |
| 20 Nov 2006 | Not recorded | Clean | |
| 1 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Feb 2009
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Lequita M Mayhew
4 Feb 2009
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Lequita M Mayhew
Investigators
FDA investigators tied to this site in the record.
Leeterry Moore3 insp.
Gabryelle J Solverud1 insp.
Lauren A Crivellone1 insp.
Jennifer C Adams1 insp.
Michael D Robinson1 insp.
Sherea L Dillon1 insp.
Russell K Riley1 insp.
Lequita M Mayhew1 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 |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.170(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 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