LA ROCHE-POSAY LABORATORIRE DERM
⚠️ High Risk
FEI: 3012964178 • La Roche Posey • FRANCE
FEI Number
3012964178
Location
La Roche Posey
Country
FRANCEAddress
av Rene Lavayr, , La Roche Posey, , France
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/20/2025 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/20/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/20/2025 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 9/2/2025 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/2/2025 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/2/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/2/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/23/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/23/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/23/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/23/2025 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/12/2025 | 66PDY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/12/2025 | 66PDY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LA ROCHE-POSAY LABORATORIRE DERM's FDA import refusal history?
LA ROCHE-POSAY LABORATORIRE DERM (FEI: 3012964178) has 13 FDA import refusal record(s) in our database, spanning from 5/12/2025 to 10/20/2025.
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. LA ROCHE-POSAY LABORATORIRE DERM's FEI number is 3012964178.
What types of violations has LA ROCHE-POSAY LABORATORIRE DERM received?
LA ROCHE-POSAY LABORATORIRE DERM has been cited for 3 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 LA ROCHE-POSAY LABORATORIRE DERM come from?
All FDA import refusal data for LA ROCHE-POSAY LABORATORIRE DERM 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.