Decleor S.A.
⚠️ Moderate Risk
FEI: 3002855456 • Paris France • FRANCE
FEI Number
3002855456
Location
Paris France
Country
FRANCEAddress
Main Street, , Paris France, , 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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/3/2003 | 53DH03POWDERS (DUSTING AND TALCUM, EXCLUDING AFTERSHAVE TALC) (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 3/13/2002 | 89IPFSTIMULATOR, MUSCLE, POWERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Decleor S.A.'s FDA import refusal history?
Decleor S.A. (FEI: 3002855456) has 2 FDA import refusal record(s) in our database, spanning from 3/13/2002 to 7/3/2003.
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. Decleor S.A.'s FEI number is 3002855456.
What types of violations has Decleor S.A. received?
Decleor S.A. has been cited for 6 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 Decleor S.A. come from?
All FDA import refusal data for Decleor S.A. 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.