BIOCODEX
⚠️ Moderate Risk
FEI: 3004258294 • Gentilly, Val de Marne • FRANCE
FEI Number
3004258294
Location
Gentilly, Val de Marne
Country
FRANCEAddress
7 avenue Gallieni, , Gentilly, Val de Marne, 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/2/2018 | 61MCF99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2016 | 62KCB99ANTI-PERISTALTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/9/2016 | 61MCE99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2014 | 61NCY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/5/2013 | 61MDB99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/4/2013 | 61MDE99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/2/2012 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 8/2/2012 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 6/18/2012 | 61MCE99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 61MIE99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 61MIE99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2012 | 61MCF99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2012 | 61MCF99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 60LAA14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/4/2006 | 61MCY99ANTI-CONVULSANT, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is BIOCODEX's FDA import refusal history?
BIOCODEX (FEI: 3004258294) has 15 FDA import refusal record(s) in our database, spanning from 5/4/2006 to 5/2/2018.
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 3004258294.
What types of violations has BIOCODEX received?
BIOCODEX 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 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.