Biotez Berlin
⚠️ Moderate Risk
FEI: 3002952102 • Berlin • GERMANY
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
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/12/2015 | 82OTRRESEARCH USE ONLY/IMMUNOLOGY DEVICES | 186INSANITARY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Biotez Berlin's FDA import refusal history?
Biotez Berlin (FEI: 3002952102) has 1 FDA import refusal record(s) in our database, spanning from 1/12/2015 to 1/12/2015.
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. Biotez Berlin's FEI number is 3002952102.
What types of violations has Biotez Berlin received?
Biotez Berlin 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 Biotez Berlin come from?
All FDA import refusal data for Biotez Berlin 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.