Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-14.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2024 – 14 May 2024 | Medical Devices & Rad Health | 483 | On file |
| 3 Jun 2019 – 4 Jun 2019 | Medical Devices & Rad Health | 483 | On file |
| 23 May 2017 – 24 May 2017 | Medical Devices & Rad Health | Clean | |
| 15 Jun 2015 | Medical Devices & Rad Health | Clean |
Investigators
FDA investigators tied to this site in the record.
Gregory M Bessette2 insp.
Nassim Ben Makhlouf1 insp.
Francis Pham1 insp.
Emir Galevi1 insp.
Andre S Lamontagne1 insp.
Michael P Sweeney1 insp.
Joseph C Teixeira1 insp.
Mark K Tseng1 insp.
Full site report
Get the verbatim findings behind this site's 2 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