DERMAQUAL SARL
⚠️ Moderate Risk
FEI: 3015495699 • Paris • FRANCE
FEI Number
3015495699
Location
Paris
Country
FRANCEAddress
76 78 Ave Des Champs El, , 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).
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.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2023 | 79QAIPOWERED MICRONEEDLE DEVICE | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 3/29/2023 | 54KYL18HORDENINE (HERBAL AND BOTANICALS, NOT TEAS II) | 488HEALTH C | Division of Northern Border Imports (DNBI) |
| 3/29/2023 | 54KYL18HORDENINE (HERBAL AND BOTANICALS, NOT TEAS II) | 488HEALTH C | Division of Northern Border Imports (DNBI) |
| 3/29/2023 | 88NQFIMMUNOHISTOCHEMISTRY ASSAY, ANTIBODY, EPIDERMAL GROWTH FACTOR RECEPTOR | Division of Northern Border Imports (DNBI) | |
| 3/29/2023 | 79QAIPOWERED MICRONEEDLE DEVICE | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is DERMAQUAL SARL's FDA import refusal history?
DERMAQUAL SARL (FEI: 3015495699) has 5 FDA import refusal record(s) in our database, spanning from 3/29/2023 to 3/29/2023.
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. DERMAQUAL SARL's FEI number is 3015495699.
What types of violations has DERMAQUAL SARL received?
DERMAQUAL SARL 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 DERMAQUAL SARL come from?
All FDA import refusal data for DERMAQUAL SARL 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.