Equipro Equipements de Beaute Inc.
⚠️ Moderate Risk
FEI: 3003751839 • Montreal-Nord, Quebec • CANADA
FEI Number
3003751839
Location
Montreal-Nord, Quebec
Country
CANADAAddress
11970 Albert-Hudon Blvd, , Montreal-Nord, 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
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).
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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2008 | 89INNCHAIR, ADJUSTABLE, MECHANICAL | New England District Office (NWE-DO) | |
| 9/29/2008 | 80FNJBED, MANUAL | New England District Office (NWE-DO) | |
| 9/29/2008 | 89INNCHAIR, ADJUSTABLE, MECHANICAL | New England District Office (NWE-DO) | |
| 9/29/2008 | 89INNCHAIR, ADJUSTABLE, MECHANICAL | New England District Office (NWE-DO) | |
| 9/29/2008 | 80LLIBED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE | New England District Office (NWE-DO) | |
| 9/29/2008 | 80LLIBED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE | New England District Office (NWE-DO) | |
| 11/28/2007 | 76ECCSTERILIZER, GLASS BEAD | New York District Office (NYK-DO) | |
| 5/3/2007 | 95U20ULTRAVIOLET PRODUCT (MISCELLANEOUS) FOR NON-MEDICAL USE | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/30/2005 | 80MKBDEVICE, GERMICIDAL, ULTRAVIOLET | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Equipro Equipements de Beaute Inc.'s FDA import refusal history?
Equipro Equipements de Beaute Inc. (FEI: 3003751839) has 9 FDA import refusal record(s) in our database, spanning from 11/30/2005 to 9/29/2008.
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. Equipro Equipements de Beaute Inc.'s FEI number is 3003751839.
What types of violations has Equipro Equipements de Beaute Inc. received?
Equipro Equipements de Beaute Inc. 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 Equipro Equipements de Beaute Inc. come from?
All FDA import refusal data for Equipro Equipements de Beaute 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.