Overview
- 11 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-16.
At a glance
Inspections
11
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Nov 2022 – 16 Nov 2022 | Human Drugs | 483 | On file |
| 16 Apr 2019 – 23 Apr 2019 | Human Drugs | Clean | |
| 29 Jul 2016 – 15 Aug 2016 | Human Drugs | Clean | |
| 9 Dec 2013 – 17 Dec 2013 | Human Drugs | Clean | |
| 30 Mar 2012 | Not recorded | Clean | |
| 8 Mar 2011 | Not recorded | 483 | On file |
| 8 May 2009 | Not recorded | 483 | On file |
| 3 May 2006 | Not recorded | Clean | |
| 5 Mar 2004 | Not recorded | Clean | |
| 15 Oct 2002 | Not recorded | Clean | |
| 5 Oct 2000 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Christopher D Leach2 insp.
Christina A Miller2 insp.
Nibin Varghese1 insp.
Enrico-Jose T Mangahis1 insp.
Nicholas P Diorio1 insp.
Brian D Nicholson1 insp.
Denarvis C Mendenhall1 insp.
Jason F Chancey1 insp.
Full site report
Get the verbatim findings behind Esteve CDMO US, Inc. dba Regis Chemical Company's 3 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