Laboratoire Bioderma
⚠️ Moderate Risk
FEI: 3002679824 • Lyon, Rhone • FRANCE
FEI Number
3002679824
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
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.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each 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 |
|---|---|---|---|
| 7/23/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Philadelphia District Office (PHI-DO) | |
| 7/23/2010 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Philadelphia District Office (PHI-DO) | |
| 5/12/2010 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 5/12/2010 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 5/12/2010 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 5/12/2010 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 6/2/2004 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 6/2/2004 | 66PCB99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/2/2004 | 66PDB99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratoire Bioderma's FDA import refusal history?
Laboratoire Bioderma (FEI: 3002679824) has 9 FDA import refusal record(s) in our database, spanning from 6/2/2004 to 7/23/2010.
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. Laboratoire Bioderma's FEI number is 3002679824.
What types of violations has Laboratoire Bioderma received?
Laboratoire Bioderma has been cited for 6 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 Laboratoire Bioderma come from?
All FDA import refusal data for Laboratoire Bioderma 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.