Lab Dermatologies Avenue France
⚠️ Moderate Risk
FEI: 3004834779 • 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).
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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 |
|---|---|---|---|
| 1/28/2008 | 64XAO99KERATOLYTIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 1/28/2008 | 64XAO99KERATOLYTIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 1/28/2008 | 65HAO01DEXTRAN 40 (PLASMA VOLUME EXTENDER) | New Orleans District Office (NOL-DO) | |
| 7/27/2006 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/27/2006 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 115DR QUALITY | New Orleans District Office (NOL-DO) |
| 7/27/2006 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Lab Dermatologies Avenue France's FDA import refusal history?
Lab Dermatologies Avenue France (FEI: 3004834779) has 6 FDA import refusal record(s) in our database, spanning from 7/27/2006 to 1/28/2008.
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. Lab Dermatologies Avenue France's FEI number is 3004834779.
What types of violations has Lab Dermatologies Avenue France received?
Lab Dermatologies Avenue France 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 Lab Dermatologies Avenue France come from?
All FDA import refusal data for Lab Dermatologies Avenue France 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.