Bioderma Laboratory
⚠️ Moderate Risk
FEI: 3003911557 • Lyon, Rhone • FRANCE
FEI Number
3003911557
Location
Lyon, Rhone
Country
FRANCEAddress
75 cours Albert Thomas, , Lyon, Rhone, 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
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.
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.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 |
|---|---|---|---|
| 4/22/2015 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 6/7/2012 | 53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/7/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/7/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/7/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/7/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/7/2012 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/7/2012 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 5/13/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 5/13/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 9/14/2005 | 66PDY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | New Orleans District Office (NOL-DO) | |
| 6/2/2004 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bioderma Laboratory's FDA import refusal history?
Bioderma Laboratory (FEI: 3003911557) has 12 FDA import refusal record(s) in our database, spanning from 6/2/2004 to 4/22/2015.
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. Bioderma Laboratory's FEI number is 3003911557.
What types of violations has Bioderma Laboratory received?
Bioderma Laboratory 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 Bioderma Laboratory come from?
All FDA import refusal data for Bioderma Laboratory 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.