Merits Health Products Co., Ltd.
⚠️ High Risk
FEI: 1000334118 • Taichung City, Taichung - Dist • TAIWAN
FEI
FEI Number
1000334118
📍
Location
Taichung City, Taichung - Dist
🇹🇼
Country
TAIWAN🏢
Address
T.P.M.T. Park Nantun District, No. 18 Jingke Rd.; Nantun Dist., Taichung City, Taichung - Dist, Taiwan
High Risk
FDA Import Risk Assessment
67.9
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
277
Total Refusals
2
Unique Violations
3/21/2012
Latest Refusal
2/2/2012
Earliest Refusal
Score Breakdown
Violation Severity
77.0×40%
Refusal Volume
90.5×30%
Recency
0.0×20%
Frequency
100.0×10%
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
290193×
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).
278084×
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Philadelphia District Office (PHI-DO) |
| 3/21/2012 | 89INIVEHICLE, MOTORIZED 3-WHEELED | 2780DEVICEGMPS | Philadelphia District Office (PHI-DO) |
| 2/23/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Philadelphia District Office (PHI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89INIVEHICLE, MOTORIZED 3-WHEELED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 80FSALIFT, PATIENT, NON-AC-POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89IMLARMREST, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 80FSALIFT, PATIENT, NON-AC-POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89IMMFOOTREST, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89IMLARMREST, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89IMLARMREST, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89INIVEHICLE, MOTORIZED 3-WHEELED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89IMLARMREST, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89IMRDEVICE, ANTI-TIP, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89IMLARMREST, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89IMLARMREST, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89IMLARMREST, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89IMMFOOTREST, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/15/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/10/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/10/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/10/2012 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 2/10/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 2780DEVICEGMPS | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89INGELEVATOR, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89INGELEVATOR, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/7/2012 | 89KNNCOMPONENTS, WHEELCHAIR | 290DE IMP GMP | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Merits Health Products Co., Ltd.'s FDA import refusal history?
Merits Health Products Co., Ltd. (FEI: 1000334118) has 277 FDA import refusal record(s) in our database, spanning from 2/2/2012 to 3/21/2012.
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. Merits Health Products Co., Ltd.'s FEI number is 1000334118.
What types of violations has Merits Health Products Co., Ltd. received?
Merits Health Products Co., Ltd. has been cited for 2 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 Merits Health Products Co., Ltd. come from?
All FDA import refusal data for Merits Health Products 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.