Laboratories Dermatologiques Ducray
⚠️ Moderate Risk
FEI: 3006575886 • Paris, Bolougne • FRANCE
FEI Number
3006575886
Location
Paris, Bolougne
Country
FRANCEAddress
45 Place Abel Cance, , Paris, Bolougne, 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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 |
|---|---|---|---|
| 6/16/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/6/2011 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/6/2011 | 65LBL99PROTECTANT N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratories Dermatologiques Ducray's FDA import refusal history?
Laboratories Dermatologiques Ducray (FEI: 3006575886) has 3 FDA import refusal record(s) in our database, spanning from 7/6/2011 to 6/16/2014.
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. Laboratories Dermatologiques Ducray's FEI number is 3006575886.
What types of violations has Laboratories Dermatologiques Ducray received?
Laboratories Dermatologiques Ducray 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 Laboratories Dermatologiques Ducray come from?
All FDA import refusal data for Laboratories Dermatologiques Ducray 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.