Boiron
⚠️ Moderate Risk
FEI: 3004611192 • Messimy, Rhone • FRANCE
FEI Number
3004611192
Location
Messimy, Rhone
Country
FRANCEAddress
2 avenue de l ouest Lyonnais, , Messimy, Rhone, 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
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
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 |
|---|---|---|---|
| 12/21/2017 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2012 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 2/9/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Baltimore District Office (BLT-DO) |
| 2/9/2011 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 117DANGEROUS | Baltimore District Office (BLT-DO) |
| 4/11/2008 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Boiron's FDA import refusal history?
Boiron (FEI: 3004611192) has 5 FDA import refusal record(s) in our database, spanning from 4/11/2008 to 12/21/2017.
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 3004611192.
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.