See Kiang Optical Manufactory Co.Ltd.
✅ Low Risk
FEI: 1000284573 • Tsuen Wan, New Territories • HONG KONG
FEI Number
1000284573
Location
Tsuen Wan, New Territories
Country
HONG KONGAddress
Super Luck Ind Ctr, 2642 Castle Peak Road, Tsuen Wan, New Territories, Hong Kong
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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
Frequently Asked Questions
What is See Kiang Optical Manufactory Co.Ltd.'s FDA import refusal history?
See Kiang Optical Manufactory Co.Ltd. (FEI: 1000284573) has 1 FDA import refusal record(s) in our database, spanning from 3/14/2013 to 3/14/2013.
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. See Kiang Optical Manufactory Co.Ltd.'s FEI number is 1000284573.
What types of violations has See Kiang Optical Manufactory Co.Ltd. received?
See Kiang Optical Manufactory 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 See Kiang Optical Manufactory Co.Ltd. come from?
All FDA import refusal data for See Kiang Optical Manufactory 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.