Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-08-16.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Aug 2017 – 16 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 21 Apr 2014 – 25 Apr 2014 | Medical Devices & Rad Health | Clean | |
| 21 Dec 2011 | Not recorded | Clean | |
| 8 Feb 2011 | Not recorded | 483 | On file |
| 18 Aug 2010 | Not recorded | WL | On file |
| 6 Sep 2007 | Not recorded | Clean | |
| 15 Mar 2007 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Michael G Mayfield2 insp.
Edward J Janik2 insp.
Camerson E Moore1 insp.
George T Allen1 insp.
Gerard J Desany1 insp.
Full site report
Get the verbatim findings behind Defibtech, LLC'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