Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2018-11-01.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Oct 2018 – 1 Nov 2018 | Medical Devices & Rad Health | 483 | On file |
| 18 Mar 2014 – 24 Mar 2014 | Medical Devices & Rad Health | Clean | |
| 10 Mar 2011 | Not recorded | Clean | |
| 15 Aug 2008 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
MDSAP WilliamsA1 insp.
James M Simpson1 insp.
Holly S Simms1 insp.
Erin L Mcfiren1 insp.
Merideth K Rose1 insp.
Cornelius Brown1 insp.
Lori S Lawless1 insp.
Stacey A Priest1 insp.
Full site report
Get the verbatim findings behind W.L. Gore & Associates, Inc.'s 1 Form 483
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