Foosin Medical Supplies Inc Ltd
⚠️ Moderate Risk
FEI: 3006562124 • Weihai • CHINA
FEI Number
3006562124
Location
Weihai
Country
CHINAAddress
Weihai, No. 20 Xingshan Road, Weihai, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/14/2024 | 79GAPSUTURE, NONABSORBABLE, SILK | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/17/2024 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/17/2024 | 79NBYSUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/17/2024 | 79NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Foosin Medical Supplies Inc Ltd's FDA import refusal history?
Foosin Medical Supplies Inc Ltd (FEI: 3006562124) has 4 FDA import refusal record(s) in our database, spanning from 1/17/2024 to 6/14/2024.
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. Foosin Medical Supplies Inc Ltd's FEI number is 3006562124.
What types of violations has Foosin Medical Supplies Inc Ltd received?
Foosin Medical Supplies Inc Ltd has been cited for 1 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 Foosin Medical Supplies Inc Ltd come from?
All FDA import refusal data for Foosin Medical Supplies Inc 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.