Bigmar-Bioren Pharmaceuticals SA
⚠️ Moderate Risk
FEI: 3002806501 • Barbengo, Ticino • SWITZERLAND
FEI Number
3002806501
Location
Barbengo, Ticino
Country
SWITZERLANDAddress
Via Cadepiano 24, , Barbengo, Ticino, Switzerland
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
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/10/2002 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 331DR QUALITC | New Orleans District Office (NOL-DO) |
| 5/16/2002 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 331DR QUALITC | New Orleans District Office (NOL-DO) |
| 11/25/2001 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bigmar-Bioren Pharmaceuticals SA's FDA import refusal history?
Bigmar-Bioren Pharmaceuticals SA (FEI: 3002806501) has 3 FDA import refusal record(s) in our database, spanning from 11/25/2001 to 6/10/2002.
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. Bigmar-Bioren Pharmaceuticals SA's FEI number is 3002806501.
What types of violations has Bigmar-Bioren Pharmaceuticals SA received?
Bigmar-Bioren Pharmaceuticals SA 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 Bigmar-Bioren Pharmaceuticals SA come from?
All FDA import refusal data for Bigmar-Bioren Pharmaceuticals SA 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.