Yiwu Ori-Power Medtech Co., Ltd.
⚠️ Moderate Risk
FEI: 3012309743 • Yiwu, Zhejiang • CHINA
FEI Number
3012309743
Location
Yiwu, Zhejiang
Country
CHINAAddress
86 Xiahe Road, Beiyuan Street, , Yiwu, Zhejiang, China
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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).
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/2/2022 | 80OVRKIT, FIRST AID, TALKING | Division of Southeast Imports (DSEI) | |
| 6/2/2022 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | Division of Southeast Imports (DSEI) | |
| 6/2/2022 | 89IMDPACK, HOT OR COLD, DISPOSABLE | Division of Southeast Imports (DSEI) | |
| 6/2/2022 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) | |
| 6/2/2022 | 90IWPGLOVE, PROTECTIVE, RADIOGRAPHIC | Division of Southeast Imports (DSEI) | |
| 10/1/2018 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of West Coast Imports (DWCI) | |
| 9/28/2018 | 79OHOFIRST AID KIT WITHOUT DRUG | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 6/7/2018 | 79OHOFIRST AID KIT WITHOUT DRUG | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 4/28/2017 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Yiwu Ori-Power Medtech Co., Ltd.'s FDA import refusal history?
Yiwu Ori-Power Medtech Co., Ltd. (FEI: 3012309743) has 9 FDA import refusal record(s) in our database, spanning from 4/28/2017 to 6/2/2022.
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. Yiwu Ori-Power Medtech Co., Ltd.'s FEI number is 3012309743.
What types of violations has Yiwu Ori-Power Medtech Co., Ltd. received?
Yiwu Ori-Power Medtech Co., Ltd. has been cited for 7 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 Yiwu Ori-Power Medtech Co., Ltd. come from?
All FDA import refusal data for Yiwu Ori-Power Medtech 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.