Overview
- 9 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-09-19.
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 |
|---|---|---|---|
| 16 Sep 2025 – 19 Sep 2025 | Biologics | Clean | |
| 8 Mar 2023 – 13 Mar 2023 | Biologics | Clean | |
| 26 Feb 2019 – 1 Mar 2019 | Biologics | Clean | |
| 10 Jan 2017 – 13 Jan 2017 | Biologics | Clean | |
| 16 Dec 2014 – 19 Dec 2014 | Biologics | Clean | |
| 26 Feb 2013 – 1 Mar 2013 | Biologics | Clean | |
| 17 Jun 2011 | Not recorded | 483 | View 483 → |
| 23 Sep 2009 | Not recorded | Clean | |
| 2 Feb 2000 | 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.
Marlene L Davis4 insp.
Lauren E Blaser1 insp.
James D Bridges1 insp.
Evelyn Taha1 insp.
Karen L Kosar1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 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
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