Sphinx Laboratories
⚠️ Moderate Risk
FEI: 3004373912 • Amsterdam, Noord-Holland • NETHERLANDS
FEI Number
3004373912
Location
Amsterdam, Noord-Holland
Country
NETHERLANDSAddress
Prinsengracht 530, , Amsterdam, Noord-Holland, Netherlands
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
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/7/2004 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 47NON STD | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sphinx Laboratories's FDA import refusal history?
Sphinx Laboratories (FEI: 3004373912) has 1 FDA import refusal record(s) in our database, spanning from 5/7/2004 to 5/7/2004.
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. Sphinx Laboratories's FEI number is 3004373912.
What types of violations has Sphinx Laboratories received?
Sphinx Laboratories 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 Sphinx Laboratories come from?
All FDA import refusal data for Sphinx Laboratories 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.