N.V. Organon
⚠️ High Risk
FEI: 3002806821 • Oss, Noord-Brabant • NETHERLANDS
FEI Number
3002806821
Location
Oss, Noord-Brabant
Country
NETHERLANDSAddress
Kloosterstraat 6, , Oss, Noord-Brabant, Netherlands
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/11/2024 | 64MDY11GANIRELIX ACETATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2024 | 64MCK11GANIRELIX ACETATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/25/2022 | 65JCY40ETONOGESTREL (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2021 | 65JAY40ETONOGESTREL (PROGESTIN) | Division of West Coast Imports (DWCI) | |
| 8/7/2020 | 60KDB15TIBOLONE (ANABOLIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2019 | 60KCB15TIBOLONE (ANABOLIC) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/5/2018 | 64GDA27DESOGESTREL/ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2018 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/26/2017 | 64GDA27DESOGESTREL/ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2016 | 64MCK04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/24/2014 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/24/2014 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 8/19/2013 | 64GDB07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/24/2013 | 64RIZ15POSTERIOR PITUITARY (HORMONE) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/24/2013 | 64MIT04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/30/2012 | 64MCK04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | Cincinnati District Office (CIN-DO) | |
| 2/22/2012 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 61WIP99A-FUNGAL N.E.C. | New York District Office (NYK-DO) | |
| 8/24/2011 | 56GCS99ANTIFUNGAL N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/5/2010 | 60LIR99ANALGESIC, N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/24/2008 | 61LBR08HEPARIN SODIUM (ANTI-COAGULANT) | Chicago District Office (CHI-DO) | |
| 12/8/2005 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/28/2005 | 64MCS04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | New York District Office (NYK-DO) | |
| 1/25/2005 | 65XCC99SPERMATICIDE N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/26/2003 | 60LDR37NALBUPHINE HCL (ANALGESIC) | Chicago District Office (CHI-DO) | |
| 3/26/2003 | 60LDR37NALBUPHINE HCL (ANALGESIC) | Chicago District Office (CHI-DO) | |
| 9/17/2002 | 60TDR15NALTREXONE (ANTAGONIST) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is N.V. Organon's FDA import refusal history?
N.V. Organon (FEI: 3002806821) has 35 FDA import refusal record(s) in our database, spanning from 9/17/2002 to 4/11/2024.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. N.V. Organon's FEI number is 3002806821.
What types of violations has N.V. Organon received?
N.V. Organon has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about N.V. Organon come from?
All FDA import refusal data for N.V. Organon is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.