L'occitane
⚠️ Moderate Risk
FEI: 2000036274 • Manosque, Alpes-de-Haute-Provence • FRANCE
FEI Number
2000036274
Location
Manosque, Alpes-de-Haute-Provence
Country
FRANCEAddress
Zi Saint Maurice, , Manosque, Alpes-de-Haute-Provence, 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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 |
|---|---|---|---|
| 10/1/2015 | 76EFWTOOTHBRUSH, MANUAL | Division of Northeast Imports (DNEI) | |
| 10/1/2015 | 76EFWTOOTHBRUSH, MANUAL | Division of Northeast Imports (DNEI) | |
| 7/11/2013 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Chicago District Office (CHI-DO) | |
| 9/7/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/7/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/7/2011 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/12/2011 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | New York District Office (NYK-DO) |
| 5/17/2004 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is L'occitane's FDA import refusal history?
L'occitane (FEI: 2000036274) has 8 FDA import refusal record(s) in our database, spanning from 5/17/2004 to 10/1/2015.
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. L'occitane's FEI number is 2000036274.
What types of violations has L'occitane received?
L'occitane has been cited for 5 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 L'occitane come from?
All FDA import refusal data for L'occitane 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.