Bit Analytical Instruments Gmbh
⚠️ Moderate Risk
FEI: 3003601075 • Schwalbach Am Taunus, Hassia • GERMANY
FEI Number
3003601075
Location
Schwalbach Am Taunus, Hassia
Country
GERMANYAddress
Am Kronberger Hang 3, , Schwalbach Am Taunus, Hassia, 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
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
Frequently Asked Questions
What is Bit Analytical Instruments Gmbh's FDA import refusal history?
Bit Analytical Instruments Gmbh (FEI: 3003601075) has 2 FDA import refusal record(s) in our database, spanning from 10/23/2003 to 10/23/2003.
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. Bit Analytical Instruments Gmbh's FEI number is 3003601075.
What types of violations has Bit Analytical Instruments Gmbh received?
Bit Analytical Instruments Gmbh 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 Bit Analytical Instruments Gmbh come from?
All FDA import refusal data for Bit Analytical Instruments Gmbh 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.