MASDEL INC.
⚠️ Moderate Risk
FEI: 3009394814 • Anjou, Quebec • CANADA
FEI Number
3009394814
Location
Anjou, Quebec
Country
CANADAAddress
9801 Rue Du Parcours, , Anjou, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/6/2016 | 89IMEPACK, HOT OR COLD, REUSEABLE | New York District Office (NYK-DO) | |
| 4/6/2016 | 89IMEPACK, HOT OR COLD, REUSEABLE | New York District Office (NYK-DO) | |
| 3/12/2013 | 89IMEPACK, HOT OR COLD, REUSEABLE | Detroit District Office (DET-DO) | |
| 3/12/2013 | 89IMEPACK, HOT OR COLD, REUSEABLE | Detroit District Office (DET-DO) | |
| 3/12/2013 | 89IMEPACK, HOT OR COLD, REUSEABLE | Detroit District Office (DET-DO) | |
| 3/12/2013 | 89IMEPACK, HOT OR COLD, REUSEABLE | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is MASDEL INC.'s FDA import refusal history?
MASDEL INC. (FEI: 3009394814) has 6 FDA import refusal record(s) in our database, spanning from 3/12/2013 to 4/6/2016.
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. MASDEL INC.'s FEI number is 3009394814.
What types of violations has MASDEL INC. received?
MASDEL INC. 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 MASDEL INC. come from?
All FDA import refusal data for MASDEL 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.