Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2011-06-30.
At a glance
Inspections
8
Form 483s
4
EIRs
6
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jun 2011 | Not recorded | Clean | |
| 12 Apr 2011 | Not recorded | Clean | |
| 20 Aug 2010 | Not recorded | 483 | On file |
| 14 Apr 2009 | Not recorded | 483 | View 483 → |
| 27 Mar 2009 | Not recorded | 483 | On file |
| 24 Mar 2009 | Not recorded | Clean | |
| 12 Jun 2008 | Not recorded | 483 | On file |
| 9 May 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Apr 2009
21 CFR 312.50
General responsibilities of sponsors
Cited by Michael Serrano, Justine Tomasso, Dawn L Wydner
Investigators
FDA investigators tied to this site in the record.
Dawn L Wydner7 insp.
Michael R Klapal1 insp.
Michael Serrano1 insp.
Justine Tomasso1 insp.
Jonee J Mearns1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 Form 483s
Source PDFs, 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