Biotem
⚠️ Moderate Risk
FEI: 3009806506 • Apprieu, Isere • FRANCE
FEI Number
3009806506
Location
Apprieu, Isere
Country
FRANCEAddress
885 Rue Alphonse Gourju, , Apprieu, Isere, France
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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/7/2018 | 88OTURESEARCH USE ONLY/PATHOLOGY | 223FALSE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Biotem's FDA import refusal history?
Biotem (FEI: 3009806506) has 1 FDA import refusal record(s) in our database, spanning from 9/7/2018 to 9/7/2018.
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. Biotem's FEI number is 3009806506.
What types of violations has Biotem received?
Biotem 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 Biotem come from?
All FDA import refusal data for Biotem 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.