Biocodex
⚠️ Moderate Risk
FEI: 3003346516 • Beauvais, Oise • FRANCE
FEI Number
3003346516
Location
Beauvais, Oise
Country
FRANCEAddress
1 avenue Blaise Pascal, , Beauvais, Oise, 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/9/2018 | 60CBK46NAPHAZOLINE HCL (ADRENERGIC) | Division of Northern Border Imports (DNBI) | |
| 6/7/2012 | 66MPF78CLOBAZAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/7/2012 | 66MPF78CLOBAZAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/7/2012 | 66MPF78CLOBAZAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/5/2012 | 61MCY99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/10/2012 | 61MCA99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/20/2012 | 61MCF99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/27/2011 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/22/2007 | 66VAH99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Biocodex's FDA import refusal history?
Biocodex (FEI: 3003346516) has 9 FDA import refusal record(s) in our database, spanning from 5/22/2007 to 8/9/2018.
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. Biocodex's FEI number is 3003346516.
What types of violations has Biocodex received?
Biocodex has been cited for 4 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 Biocodex come from?
All FDA import refusal data for Biocodex 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.