N.V. Organon — FDA Facility Profile

FEI 3002806821

N.V. Organon is an FDA-registered facility (FEI 3002806821) located in Oss Noord-Brabant, NL. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 11 FDA inspections at this facility.

Reviewing N.V. Organon as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check N.V. Organon yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

What FDA found at this site

Latest inspection
Sep 8, 2022: No Action Indicated (NAI)
Inspections on record
11 (4 VAI, 7 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Showing the 10 most recent of 11 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Sep 8, 2022No Action Indicated (NAI)No citations listed
Aug 25, 2022Voluntary Action Indicated (VAI)No citations listed
Sep 20, 2019No Action Indicated (NAI)No citations listed
Sep 10, 2019No Action Indicated (NAI)No citations listed
Sep 7, 2017Voluntary Action Indicated (VAI)No citations listed
Jun 8, 2016Voluntary Action Indicated (VAI)No citations listed
Feb 7, 2014Voluntary Action Indicated (VAI)No citations listed
Apr 5, 2013No Action Indicated (NAI)No citations listed
Oct 26, 2012No Action Indicated (NAI)No citations listed
Jul 2, 2010No Action Indicated (NAI)No citations listed

Facility details

Company
N.V. Organon
Location
Oss Noord-Brabant (NL)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; STERILIZE
Source
both

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.