Jinhua Jingdi Medical Supplies Co., Ltd.
⚠️ Moderate Risk
FEI: 3009486864 • Jinhua, Zhejiang • CHINA
FEI Number
3009486864
Location
Jinhua, Zhejiang
Country
CHINAAddress
88 Innovation Road, Xiaoshun, Jindong, Jinhua, 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
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/9/2025 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northern Border Imports (DNBI) | |
| 6/9/2025 | 60QBL56BENZOCAINE (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 4/13/2020 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of Southeast Imports (DSEI) | |
| 8/22/2018 | 79OHOFIRST AID KIT WITHOUT DRUG | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Jinhua Jingdi Medical Supplies Co., Ltd.'s FDA import refusal history?
Jinhua Jingdi Medical Supplies Co., Ltd. (FEI: 3009486864) has 4 FDA import refusal record(s) in our database, spanning from 8/22/2018 to 6/9/2025.
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. Jinhua Jingdi Medical Supplies Co., Ltd.'s FEI number is 3009486864.
What types of violations has Jinhua Jingdi Medical Supplies Co., Ltd. received?
Jinhua Jingdi Medical Supplies Co., Ltd. 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 Jinhua Jingdi Medical Supplies Co., Ltd. come from?
All FDA import refusal data for Jinhua Jingdi Medical Supplies 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.