Overview
- 11 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-16.
At a glance
Inspections
11
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Dec 2022 – 16 Dec 2022 | Biologics | 483 | On file |
| 8 Apr 2019 – 16 Apr 2019 | Biologics | 483 | On file |
| 9 Jan 2017 – 17 Jan 2017 | Biologics | 483 | On file |
| 26 Feb 2015 – 5 Mar 2015 | Biologics | 483 | On file |
| 18 Dec 2012 | Not recorded | 483 | On file |
| 7 Aug 2012 | Not recorded | 483 | On file |
| 24 Sep 2010 | Not recorded | 483 | On file |
| 23 Sep 2010 | Not recorded | 483 | On file |
| 31 Jul 2008 | Not recorded | 483 | On file |
| 31 Mar 2006 | Not recorded | Clean | |
| 20 Jan 2006 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry3 insp.
Omotunde O Osunsanmi3 insp.
Cynthia Jim2 insp.
Roger F Zabinski1 insp.
Yonggang Wang1 insp.
Debra M Emerson1 insp.
Lu Deng1 insp.
Mihaly S Ligmond1 insp.
Prabhu P Raju1 insp.
Parul M Patel1 insp.
Randa Melhem1 insp.
Anthony F Lorenzo1 insp.
Jie He1 insp.
Gang Wang1 insp.
Full site report
Get the verbatim findings behind this site's 9 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