H & A Mui Enterprises, Inc.
⚠️ Moderate Risk
FEI: 3002807135 • Mississauga, Ontario • CANADA
FEI Number
3002807135
Location
Mississauga, Ontario
Country
CANADAAddress
145 Traders Blvd E Unit 34, , Mississauga, Ontario, 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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).
DEVICE GMP
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/4/2017 | 79GBACATHETER, BALLOON TYPE | New York District Office (NYK-DO) | |
| 5/15/2015 | 78FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 2/24/2015 | 78FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) | 3724DEVGMPS | Detroit District Office (DET-DO) |
| 9/23/2014 | 78FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) | 2780DEVICEGMPS | Detroit District Office (DET-DO) |
| 12/31/2013 | 78FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 5/3/2013 | 78FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 11/27/2012 | 78FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) | 2780DEVICEGMPS | Detroit District Office (DET-DO) |
| 6/20/2012 | 78FFXSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) | 226DEVICE GMP | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is H & A Mui Enterprises, Inc.'s FDA import refusal history?
H & A Mui Enterprises, Inc. (FEI: 3002807135) has 8 FDA import refusal record(s) in our database, spanning from 6/20/2012 to 1/4/2017.
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. H & A Mui Enterprises, Inc.'s FEI number is 3002807135.
What types of violations has H & A Mui Enterprises, Inc. received?
H & A Mui Enterprises, 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 H & A Mui Enterprises, Inc. come from?
All FDA import refusal data for H & A Mui Enterprises, 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.