U N D A
⚠️ Moderate Risk
FEI: 3003708614 • Brussel • BELGIUM
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
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 61KAA06BELLADONNA (EXT) (ANTI-CHOLINERGIC) | 336INCONSPICU | Detroit District Office (DET-DO) |
| 10/22/2004 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is U N D A's FDA import refusal history?
U N D A (FEI: 3003708614) has 20 FDA import refusal record(s) in our database, spanning from 10/22/2004 to 10/22/2004.
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. U N D A's FEI number is 3003708614.
What types of violations has U N D A received?
U N D A has been cited for 1 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 U N D A come from?
All FDA import refusal data for U N D A 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.