Shin Chang Medical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003169040 • Gumi, Gyeongsangbuk • SOUTH KOREA
FEI Number
3003169040
Location
Gumi, Gyeongsangbuk
Country
SOUTH KOREAAddress
144 1gongdan-Ro 6-Gil, , Gumi, Gyeongsangbuk, South Korea
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
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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/5/2024 | 80FMFSYRINGE, PISTON | 126FAILS STD | Division of Southeast Imports (DSEI) |
| 2/5/2019 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 2/5/2019 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 2/5/2019 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 6/13/2005 | 74DQFACTUATOR, SYRINGE, INJECTOR TYPE | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Shin Chang Medical Co., Ltd.'s FDA import refusal history?
Shin Chang Medical Co., Ltd. (FEI: 3003169040) has 5 FDA import refusal record(s) in our database, spanning from 6/13/2005 to 8/5/2024.
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. Shin Chang Medical Co., Ltd.'s FEI number is 3003169040.
What types of violations has Shin Chang Medical Co., Ltd. received?
Shin Chang Medical Co., Ltd. has been cited for 3 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 Shin Chang Medical Co., Ltd. come from?
All FDA import refusal data for Shin Chang Medical 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.