Cheminova International Sa
⚠️ Moderate Risk
FEI: 1000156146 • Madrid, Madrid • SPAIN
FEI Number
1000156146
Location
Madrid, Madrid
Country
SPAINAddress
Calle Macarena 14, , Madrid, Madrid, Spain
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2010 | 61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/11/2005 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/11/2005 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2004 | 61HDQ05ZINC PYRITHIONE (ANTI-BACTERIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/5/2002 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Cheminova International Sa's FDA import refusal history?
Cheminova International Sa (FEI: 1000156146) has 5 FDA import refusal record(s) in our database, spanning from 4/5/2002 to 12/3/2010.
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. Cheminova International Sa's FEI number is 1000156146.
What types of violations has Cheminova International Sa received?
Cheminova International Sa has been cited for 2 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 Cheminova International Sa come from?
All FDA import refusal data for Cheminova International Sa 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.