Overview
- 10 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-06-16.
At a glance
Inspections
10
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jun 2015 | Medical Devices & Rad Health | Clean | |
| 2 Dec 2013 – 4 Dec 2013 | Medical Devices & Rad Health | 483 | On file |
| 28 May 2011 | Not recorded | 483 | On file |
| 29 Apr 2010 | Not recorded | Clean | |
| 28 Apr 2009 | Not recorded | Clean | |
| 26 Apr 2008 | Not recorded | 483 | On file |
| 18 May 2007 | Not recorded | Clean | |
| 22 Sep 2006 | Not recorded | Clean | |
| 17 Jun 2005 | Not recorded | Clean | |
| 15 Mar 2004 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Emir Galevi5 insp.
Francis J Eng2 insp.
Michael P Sweeney1 insp.
Joseph C Teixeira1 insp.
Mark K Tseng1 insp.
Andre S Lamontagne1 insp.
Full site report
Get the verbatim findings behind this site's 3 Form 483s
The full inspection record, as Atlas holds it, 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