Home / Facilities / 3007647000

Novo Nordisk Production Belgium SA — FDA Facility Profile

FEI 3007647000

Novo Nordisk Production Belgium SA is an FDA-registered facility (FEI 3007647000) located in BE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 12 FDA inspections at this facility.

Reviewing Novo Nordisk Production Belgium SA 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 Novo Nordisk Production Belgium SA 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
Apr 7, 2023: Voluntary Action Indicated (VAI)
Inspections on record
12 (10 VAI, 2 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
Form 483 and inspection documents
2 in FDA's reading room

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 12 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 7, 2023Voluntary Action Indicated (VAI)No citations listed
Aug 19, 2022Voluntary Action Indicated (VAI)No citations listed
Jan 22, 2020Voluntary Action Indicated (VAI)No citations listed
Jun 19, 2019Voluntary Action Indicated (VAI)Procedures for sterile drug products (21 CFR 211.113(b))
Complete Test Data (21 CFR 211.194(a)(4))
Control procedures to monitor and validate performance (21 CFR 211.110(a))
Jul 31, 2018No Action Indicated (NAI)No citations listed
Jul 7, 2017Voluntary Action Indicated (VAI)No citations listed
Nov 25, 2016No Action Indicated (NAI)Cleaning System (21 CFR 211.42(c)(10)(v))
Procedures for sterile drug products (21 CFR 211.113(b))
May 28, 2015Voluntary Action Indicated (VAI)No citations listed
Feb 13, 2015Voluntary Action Indicated (VAI)No citations listed
Jan 30, 2013Voluntary Action Indicated (VAI)No citations listed

Form 483s and inspection documents

Facility details

Company
Novo Nordisk Production Belgium SA
Location
BE
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

FDA data resources

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