Overview
- 14 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-09-10.
At a glance
Inspections
14
Form 483s
7
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Sep 2019 – 10 Sep 2019 | Human Drugs | Clean | |
| 30 Oct 2017 – 7 Nov 2017 | Human Drugs | 483 | On file |
| 28 Aug 2017 – 7 Sep 2017 | Human Drugs | 483 | On file |
| 6 Jun 2016 – 8 Jun 2016 | Human Drugs | 483 | On file |
| 2 Apr 2014 – 8 Apr 2014 | Biologics | 483 | On file |
| 3 Feb 2014 – 7 Feb 2014 | Human Drugs | 483 | On file |
| 25 Mar 2013 – 5 Apr 2013 | Human Drugs | Clean | |
| 26 Oct 2012 | Not recorded | Clean | |
| 9 Dec 2010 | Not recorded | 483 | On file |
| 14 May 2009 | Not recorded | Clean | |
| 23 Apr 2008 | Not recorded | 483 | On file |
| 28 Jun 2006 | Not recorded | Clean | |
Investigators
FDA investigators tied to this site in the record.
Bonita S Chester2 insp.
Steven M Weinman1 insp.
Reyes Candau-Chacon1 insp.
Dennis Cantellops Paite1 insp.
Jose A Cruz Gonzalez1 insp.
Richard H Coats1 insp.
Nicole K Trudel1 insp.
Kimberley A Hoefen1 insp.
Kham Phommachanh1 insp.
James D Planchon1 insp.
Steven C Madzo1 insp.
Frank W Perrella1 insp.
Douglas A Campbell1 insp.
Marvin D Jones1 insp.
Patrick L Wisor1 insp.
Full site report
Get the verbatim findings behind N.V. Organon's 7 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