Leonor Greyl SAS
⚠️ Moderate Risk
FEI: 1000296765 • Paris, Paris • FRANCE
FEI Number
1000296765
Location
Paris, Paris
Country
FRANCEAddress
29 rue du Terrage, , Paris, Paris, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/14/2017 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 6/11/2015 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 6/11/2015 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 2/17/2007 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Leonor Greyl SAS's FDA import refusal history?
Leonor Greyl SAS (FEI: 1000296765) has 4 FDA import refusal record(s) in our database, spanning from 2/17/2007 to 3/14/2017.
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. Leonor Greyl SAS's FEI number is 1000296765.
What types of violations has Leonor Greyl SAS received?
Leonor Greyl SAS 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 Leonor Greyl SAS come from?
All FDA import refusal data for Leonor Greyl SAS 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.