Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-06-13.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jun 2019 | Medical Devices & Rad Health | 483 | On file |
| 5 Jun 2017 – 6 Jun 2017 | Medical Devices & Rad Health | Clean | |
| 18 Jun 2015 | Medical Devices & Rad Health | Clean | |
| 11 May 2010 | Not recorded | 483 | View 483 → |
| 18 Apr 2008 | Not recorded | 483 | On file |
| 24 Oct 2005 | Not recorded | Clean | |
| 6 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 May 2010
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Andre S Lamontagne
Investigators
FDA investigators tied to this site in the record.
Andre S Lamontagne3 insp.
Emir Galevi2 insp.
Gregory M Bessette1 insp.
Francis Pham1 insp.
Michael P Sweeney1 insp.
Joseph C Teixeira1 insp.
Mark K Tseng1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1010.2(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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