Suzhou Medsport Products Co., Ltd.
⚠️ Moderate Risk
FEI: 3004950647 • Suzhou, Suzhou • CHINA
FEI Number
3004950647
Location
Suzhou, Suzhou
Country
CHINAAddress
128 Fangzhou Rd, Suzhou Industrial Park, Loufeng East District, Suzhou, Suzhou, 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).
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 |
|---|---|---|---|
| 12/27/2018 | 80FQMBANDAGE, ELASTIC | Division of Southwest Imports (DSWI) | |
| 3/26/2015 | 80FQMBANDAGE, ELASTIC | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/26/2015 | 80FQMBANDAGE, ELASTIC | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/26/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/26/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/5/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 341REGISTERED | San Francisco District Office (SAN-DO) |
| 1/23/2015 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Suzhou Medsport Products Co., Ltd.'s FDA import refusal history?
Suzhou Medsport Products Co., Ltd. (FEI: 3004950647) has 7 FDA import refusal record(s) in our database, spanning from 1/23/2015 to 12/27/2018.
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. Suzhou Medsport Products Co., Ltd.'s FEI number is 3004950647.
What types of violations has Suzhou Medsport Products Co., Ltd. received?
Suzhou Medsport 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 Suzhou Medsport Products Co., Ltd. come from?
All FDA import refusal data for Suzhou Medsport 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.