Overview
- 17 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-08-19.
At a glance
Inspections
17
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Aug 2022 – 19 Aug 2022 | Biologics | Clean | |
| 23 Oct 2018 – 30 Oct 2018 | Biologics | Clean | |
| 4 Oct 2016 – 12 Oct 2016 | Biologics | Clean | |
| 6 Jan 2015 – 9 Jan 2015 | Biologics | Clean | |
| 31 Dec 2013 | Biologics | Clean | |
| 18 Nov 2013 – 21 Nov 2013 | Biologics | Clean | |
| 4 Nov 2013 – 12 Nov 2013 | Biologics | Clean | |
| 2 Oct 2012 | Not recorded | 483 | View 483 → |
| 19 Jun 2012 | Not recorded | Clean | |
| 29 Sep 2011 | Not recorded | Clean | |
| 15 Sep 2010 | Not recorded | Clean | |
| 18 Sep 2009 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Oct 2012
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Bradley E Benasutti, Michele M Falchek
Investigators
FDA investigators tied to this site in the record.
Cara M Minelli5 insp.
Bradley E Benasutti5 insp.
Michele M Falchek5 insp.
Ann-Marie Karnick3 insp.
Dawn D Aiello1 insp.
Kimberly A Dux1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(a) | 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