Francopia (Sanofi Chimie)
⚠️ Moderate Risk
FEI: 3003308056 • Paris, Paris • FRANCE
FEI Number
3003308056
Location
Paris, Paris
Country
FRANCEAddress
174 Avenue De France, , Paris, Paris, 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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/26/2019 | 61XCY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/31/2012 | 61MDB30VALPROATE SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/9/2012 | 61LCC38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/3/2011 | 60TCA99ANTAGONIST, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/17/2011 | 64BCB25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 8/5/2011 | 62CCB99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/5/2011 | 62VIA99ANTI-VIRAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/3/2009 | 61LCY29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/1/2008 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/28/2008 | 80LDQDEVICE, GENERAL MEDICAL | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 9/24/2007 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 7/20/2005 | 61LDY38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/18/2004 | 63RDJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/28/2004 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/31/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/10/2003 | 63RBL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Francopia (Sanofi Chimie)'s FDA import refusal history?
Francopia (Sanofi Chimie) (FEI: 3003308056) has 16 FDA import refusal record(s) in our database, spanning from 10/10/2003 to 12/26/2019.
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. Francopia (Sanofi Chimie)'s FEI number is 3003308056.
What types of violations has Francopia (Sanofi Chimie) received?
Francopia (Sanofi Chimie) has been cited for 6 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 Francopia (Sanofi Chimie) come from?
All FDA import refusal data for Francopia (Sanofi Chimie) 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.