Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-30.
At a glance
Inspections
11
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2025 – 30 Jul 2025 | Biologics | 483 | On file |
| 4 Sep 2019 – 12 Sep 2019 | Biologics | 483 | On file |
| 23 Aug 2017 – 28 Aug 2017 | Biologics | Clean | |
| 15 Oct 2015 – 22 Oct 2015 | Biologics | Clean | |
| 14 Nov 2013 – 21 Nov 2013 | Biologics | 483 | On file |
| 21 Mar 2012 | Not recorded | 483 | On file |
| 28 Jan 2010 | Not recorded | 483 | On file |
| 16 Apr 2008 | Not recorded | 483 | On file |
| 23 Jun 2005 | Not recorded | Clean | |
| 17 Apr 2003 | Not recorded | Clean | |
| 26 Jan 2000 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry2 insp.
Peng Zhou1 insp.
Lizaida Perez1 insp.
Peter S Kessler1 insp.
Debra M Emerson1 insp.
Ze Peng1 insp.
Michele L Forster1 insp.
Prabhu P Raju1 insp.
Jacqueline M Diaz Albert1 insp.
Omotunde O Osunsanmi1 insp.
Melissa J Holz1 insp.
Mihaly S Ligmond1 insp.
Full site report
Get the verbatim findings behind GenTrac Inc.'s 6 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