Suzhou 66 Vision Tech Co., Ltd.
⚠️ Moderate Risk
FEI: 3003553186 • Suzhou, Jiangsu • CHINA
FEI Number
3003553186
Location
Suzhou, Jiangsu
Country
CHINAAddress
Bldg. 2, No. 9 Jinfeng Rd., Suzhou, Jiangsu, 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2019 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | Division of Northern Border Imports (DNBI) | |
| 7/27/2017 | 86HKLRETINOSCOPE, AC-POWERED | Division of West Coast Imports (DWCI) | |
| 7/24/2017 | 86HKLRETINOSCOPE, AC-POWERED | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 7/20/2017 | 86HKLRETINOSCOPE, AC-POWERED | Division of West Coast Imports (DWCI) | |
| 10/18/2006 | 86HLIOPHTHALMOSCOPE, AC-POWERED | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 4/20/2004 | 89INQTABLE, POWERED | Florida District Office (FLA-DO) | |
| 4/20/2004 | 86HNCSPECULA, OPHTHALMIC | Florida District Office (FLA-DO) | |
| 4/20/2004 | 86HNRFORCEPS, OPHTHALMIC | Florida District Office (FLA-DO) | |
| 4/20/2004 | 86HNRFORCEPS, OPHTHALMIC | Florida District Office (FLA-DO) | |
| 4/20/2004 | 86HNFSCISSORS, OPHTHALMIC | Florida District Office (FLA-DO) | |
| 4/20/2004 | 86HNNKNIFE, OPHTHALMIC | Florida District Office (FLA-DO) | |
| 4/20/2004 | 86HLJOPHTHALMOSCOPE, BATTERY-POWERED | Florida District Office (FLA-DO) | |
| 4/20/2004 | 86NCFABERROMETER, OPHTHALMIC | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Suzhou 66 Vision Tech Co., Ltd.'s FDA import refusal history?
Suzhou 66 Vision Tech Co., Ltd. (FEI: 3003553186) has 13 FDA import refusal record(s) in our database, spanning from 4/20/2004 to 11/7/2019.
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 66 Vision Tech Co., Ltd.'s FEI number is 3003553186.
What types of violations has Suzhou 66 Vision Tech Co., Ltd. received?
Suzhou 66 Vision Tech 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 Suzhou 66 Vision Tech Co., Ltd. come from?
All FDA import refusal data for Suzhou 66 Vision Tech 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.