Laboratoires Expanscience
⚠️ Moderate Risk
FEI: 3011921873 • Epernon • FRANCE
FEI Number
3011921873
Location
Epernon
Country
FRANCEAddress
Rue Des 4 (Quatre) Filles, , Epernon, , 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
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2023 | 41YYY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2018 | 66VBE99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 8/9/2018 | 66VBE99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Laboratoires Expanscience's FDA import refusal history?
Laboratoires Expanscience (FEI: 3011921873) has 3 FDA import refusal record(s) in our database, spanning from 8/9/2018 to 9/29/2023.
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. Laboratoires Expanscience's FEI number is 3011921873.
What types of violations has Laboratoires Expanscience received?
Laboratoires Expanscience 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 Laboratoires Expanscience come from?
All FDA import refusal data for Laboratoires Expanscience 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.