HONG KONG OPTICAL LENS CO., LTD.
⚠️ Moderate Risk
FEI: 3038389534 • Hong Kong • HONG KONG
FEI Number
3038389534
Location
Hong Kong
Country
HONG KONGAddress
Rm 14&15 ,11/F Kwong Sang Hong Ctr, 15- 153 Hoi Bu, , Hong Kong, , Hong Kong
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).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
Refusal History
Frequently Asked Questions
What is HONG KONG OPTICAL LENS CO., LTD.'s FDA import refusal history?
HONG KONG OPTICAL LENS CO., LTD. (FEI: 3038389534) has 1 FDA import refusal record(s) in our database, spanning from 3/31/2025 to 3/31/2025.
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. HONG KONG OPTICAL LENS CO., LTD.'s FEI number is 3038389534.
What types of violations has HONG KONG OPTICAL LENS CO., LTD. received?
HONG KONG OPTICAL LENS CO., LTD. has been cited for 5 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 HONG KONG OPTICAL LENS CO., LTD. come from?
All FDA import refusal data for HONG KONG OPTICAL LENS 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.