Overview
- 13 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-26.
At a glance
Inspections
13
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Sep 2025 – 26 Sep 2025 | Human Drugs | Clean | |
| 24 Feb 2021 – 3 Mar 2021 | Human Drugs | Clean | |
| 9 Jan 2016 – 27 Jan 2016 | Human Drugs | Clean | |
| 9 Oct 2013 – 28 Oct 2013 | Human Drugs | 483 | On file |
| 7 Dec 2012 | Not recorded | 483 | On file |
| 27 Jan 2012 | Not recorded | Clean | |
| 20 Dec 2010 | Not recorded | Clean | |
| 17 Aug 2010 | Not recorded | Clean | |
| 24 Nov 2009 | Not recorded | Clean | |
| 23 Jan 2008 | Not recorded | Clean | |
| 8 Mar 2004 | Not recorded | Clean | |
| 1 Jul 2002 | Not recorded | Clean | |
Investigators
FDA investigators tied to this site in the record.
Demitria J Xiradakis6 insp.
Sony Mathews2 insp.
Raihan A Chowdhury1 insp.
Gam S Zamil1 insp.
Satheesh Thomas1 insp.
Simone E Pitts1 insp.
Full site report
Get the verbatim findings behind ENDO USA, Inc'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