Bioderma Laboratoire
⚠️ Moderate Risk
FEI: 3006318715 • Aix-Enprovence • FRANCE
FEI Number
3006318715
Location
Aix-Enprovence
Country
FRANCEAddress
F 69447 Lyon Cedex, , Aix-Enprovence, , 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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/28/2014 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 7/28/2014 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 10/21/2011 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Bioderma Laboratoire's FDA import refusal history?
Bioderma Laboratoire (FEI: 3006318715) has 3 FDA import refusal record(s) in our database, spanning from 10/21/2011 to 7/28/2014.
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. Bioderma Laboratoire's FEI number is 3006318715.
What types of violations has Bioderma Laboratoire received?
Bioderma Laboratoire has been cited for 4 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 Bioderma Laboratoire come from?
All FDA import refusal data for Bioderma Laboratoire 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.