Boiron
⚠️ Moderate Risk
FEI: 3003486694 • Montrichard Val De Cher, Loir Et Cher • FRANCE
FEI Number
3003486694
Location
Montrichard Val De Cher, Loir Et Cher
Country
FRANCEAddress
3 Rue De La Tonnarderie, Montrichard, Montrichard Val De Cher, Loir Et Cher, 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/6/2005 | 66VAS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 6/6/2005 | 66VAS99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/4/2002 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 11/30/2001 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Boiron's FDA import refusal history?
Boiron (FEI: 3003486694) has 4 FDA import refusal record(s) in our database, spanning from 11/30/2001 to 6/6/2005.
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. Boiron's FEI number is 3003486694.
What types of violations has Boiron received?
Boiron has been cited for 3 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 Boiron come from?
All FDA import refusal data for Boiron 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.