Sdx
⚠️ High Risk
FEI: 3003646846 • Utrecht, Utrecht • NETHERLANDS
FEI Number
3003646846
Location
Utrecht, Utrecht
Country
NETHERLANDSAddress
Kernkade 4l, , Utrecht, Utrecht, 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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2003 | 66SCA99VASODILATOR N.E.C. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 66SCA99VASODILATOR N.E.C. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 66BAA19METHYLPHENIDATE HCL (STIMULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 65PCA99REGULATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/3/2003 | 66BAA19METHYLPHENIDATE HCL (STIMULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/12/2003 | 64RBY99HORMONE N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/7/2003 | 64RBY99HORMONE N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/18/2003 | 66SCA99VASODILATOR N.E.C. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/17/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/14/2003 | 66SCA99VASODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/9/2003 | 64RBY99HORMONE N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/27/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sdx's FDA import refusal history?
Sdx (FEI: 3003646846) has 26 FDA import refusal record(s) in our database, spanning from 8/27/2003 to 12/3/2003.
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. Sdx's FEI number is 3003646846.
What types of violations has Sdx received?
Sdx 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 Sdx come from?
All FDA import refusal data for Sdx 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.