Overview
- 9 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-11-06.
At a glance
Inspections
9
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Nov 2024 | Biologics | Clean | |
| 6 May 2019 – 7 May 2019 | Biologics | Clean | |
| 20 Mar 2017 – 21 Mar 2017 | Biologics | 483 | View 483 → |
| 27 Apr 2015 – 28 Apr 2015 | Biologics | Clean | |
| 16 Apr 2013 – 17 Apr 2013 | Biologics | Clean | |
| 19 Apr 2011 | Not recorded | Clean | |
| 19 Mar 2009 | Not recorded | Clean | |
| 4 Apr 2005 | Not recorded | Clean | |
| 29 Mar 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Ava M Bowman2 insp.
Paul M Chefor1 insp.
Travis S Bradley1 insp.
Peter S Kessler1 insp.
Young M Yoon1 insp.
Alexander M Kay1 insp.
Dolores E Price1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 1 Form 483
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