Mean Chyee International Industry
⚠️ Moderate Risk
FEI: 3010803452 • Taipei • TAIWAN
FEI Number
3010803452
Location
Taipei
Country
TAIWANAddress
No 15-1 Ziqiang Rdtaishan Shiang, , Taipei, , Taiwan
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).
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.
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 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 |
|---|---|---|---|
| 10/31/2014 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Los Angeles District Office (LOS-DO) | |
| 10/31/2014 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Los Angeles District Office (LOS-DO) | |
| 10/31/2014 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Los Angeles District Office (LOS-DO) | |
| 10/31/2014 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Los Angeles District Office (LOS-DO) | |
| 10/31/2014 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Los Angeles District Office (LOS-DO) | |
| 10/31/2014 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Los Angeles District Office (LOS-DO) | |
| 10/31/2014 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Mean Chyee International Industry's FDA import refusal history?
Mean Chyee International Industry (FEI: 3010803452) has 7 FDA import refusal record(s) in our database, spanning from 10/31/2014 to 10/31/2014.
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. Mean Chyee International Industry's FEI number is 3010803452.
What types of violations has Mean Chyee International Industry received?
Mean Chyee International Industry 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 Mean Chyee International Industry come from?
All FDA import refusal data for Mean Chyee International Industry 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.