MING FAI ENTERPRISE INTERNATIONAL CO., LTD
⚠️ Moderate Risk
FEI: 3007143236 • Tuen Mun, New Territories • HONG KONG
FEI Number
3007143236
Location
Tuen Mun, New Territories
Country
HONG KONGAddress
3/F, Mai Kei Industrial Building Bldg. No.; 5 San Hop Lane, Tuen Mun, New Territories, Hong Kong
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2017 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/31/2010 | 62WI17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/28/2009 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | San Francisco District Office (SAN-DO) |
| 3/23/2005 | 76EFWTOOTHBRUSH, MANUAL | Los Angeles District Office (LOS-DO) | |
| 3/5/2005 | 53EY02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 251POISONOUS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is MING FAI ENTERPRISE INTERNATIONAL CO., LTD's FDA import refusal history?
MING FAI ENTERPRISE INTERNATIONAL CO., LTD (FEI: 3007143236) has 5 FDA import refusal record(s) in our database, spanning from 3/5/2005 to 6/13/2017.
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. MING FAI ENTERPRISE INTERNATIONAL CO., LTD's FEI number is 3007143236.
What types of violations has MING FAI ENTERPRISE INTERNATIONAL CO., LTD received?
MING FAI ENTERPRISE INTERNATIONAL CO., LTD has been cited for 5 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 MING FAI ENTERPRISE INTERNATIONAL CO., LTD come from?
All FDA import refusal data for MING FAI ENTERPRISE INTERNATIONAL CO., LTD 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.