Elancyl
⚠️ Moderate Risk
FEI: 3007632499 • Boulogne Billancourt, Hauts de Seine • FRANCE
FEI Number
3007632499
Location
Boulogne Billancourt, Hauts de Seine
Country
FRANCEAddress
45 Place Abel Gance, , Boulogne Billancourt, Hauts de Seine, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/23/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Philadelphia District Office (PHI-DO) | |
| 7/23/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Philadelphia District Office (PHI-DO) | |
| 7/23/2010 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/12/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 5/12/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Elancyl's FDA import refusal history?
Elancyl (FEI: 3007632499) has 5 FDA import refusal record(s) in our database, spanning from 5/12/2010 to 7/23/2010.
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. Elancyl's FEI number is 3007632499.
What types of violations has Elancyl received?
Elancyl 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 Elancyl come from?
All FDA import refusal data for Elancyl 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.