Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-30.
At a glance
Inspections
8
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Apr 2025 – 30 Apr 2025 | Biologics | Clean | |
| 3 Apr 2018 – 4 Apr 2018 | Biologics | Clean | |
| 21 Dec 2015 – 22 Dec 2015 | Biologics | Clean | |
| 7 Oct 2013 – 15 Oct 2013 | Biologics | 483 | View 483 → |
| 5 Apr 2012 | Not recorded | Clean | |
| 22 Feb 2010 | Not recorded | 483 | View 483 → |
| 2 Jul 2008 | Not recorded | Clean | |
| 15 Feb 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Feb 2010
21 CFR 1271.270(e)
Contract firms--identities and responsibilities
Cited by Michael G Sinkevich
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.260(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.265(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.265(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(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