Biosyn Arzneimittel Gmbh
⚠️ Moderate Risk
FEI: 3004129048 • Fellbach, Baden-Wurttemberg • GERMANY
FEI Number
3004129048
Location
Fellbach, Baden-Wurttemberg
Country
GERMANYAddress
Eberhardstr. 64, , Fellbach, Baden-Wurttemberg, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Biosyn Arzneimittel Gmbh's FDA import refusal history?
Biosyn Arzneimittel Gmbh (FEI: 3004129048) has 1 FDA import refusal record(s) in our database, spanning from 10/6/2003 to 10/6/2003.
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. Biosyn Arzneimittel Gmbh's FEI number is 3004129048.
What types of violations has Biosyn Arzneimittel Gmbh received?
Biosyn Arzneimittel Gmbh 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 Biosyn Arzneimittel Gmbh come from?
All FDA import refusal data for Biosyn Arzneimittel 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.