DERMADRY LABORATORIES INC
⚠️ Moderate Risk
FEI: 3015099059 • Montreal, Quebec • CANADA
FEI Number
3015099059
Location
Montreal, Quebec
Country
CANADAAddress
5824, Rue D'Iberville, , Montreal, Quebec, Canada
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
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/1/2024 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | Division of Southeast Imports (DSEI) | |
| 10/29/2021 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | Division of Southeast Imports (DSEI) | |
| 2/16/2021 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | Division of Southeast Imports (DSEI) | |
| 9/14/2020 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/8/2020 | 79OUBINSTRUMENT FOR TREATMENT OF HYPERHIDROSIS | Division of Southeast Imports (DSEI) | |
| 12/4/2019 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | Division of Southeast Imports (DSEI) | |
| 11/12/2019 | 89KTBDEVICE, IONTOPHORESIS, SPECIFIC USES | Division of Southeast Imports (DSEI) | |
| 10/21/2019 | 79OUBINSTRUMENT FOR TREATMENT OF HYPERHIDROSIS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DERMADRY LABORATORIES INC's FDA import refusal history?
DERMADRY LABORATORIES INC (FEI: 3015099059) has 8 FDA import refusal record(s) in our database, spanning from 10/21/2019 to 10/1/2024.
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. DERMADRY LABORATORIES INC's FEI number is 3015099059.
What types of violations has DERMADRY LABORATORIES INC received?
DERMADRY LABORATORIES INC 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 DERMADRY LABORATORIES INC come from?
All FDA import refusal data for DERMADRY LABORATORIES INC 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.