Carl Zeiss Vision Sunlens Asia Pacific Ltd.
✅ Low Risk
FEI: 3003344414 • NT • HONG KONG
FEI Number
3003344414
Location
NT
Country
HONG KONGAddress
Delta House, 3rd. Floor, Unit 1315, 3 On Yiu Street, Shatin, NT, , 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
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).
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.
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 |
|---|---|---|---|
| 6/3/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 12/30/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 12/4/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Carl Zeiss Vision Sunlens Asia Pacific Ltd.'s FDA import refusal history?
Carl Zeiss Vision Sunlens Asia Pacific Ltd. (FEI: 3003344414) has 3 FDA import refusal record(s) in our database, spanning from 12/4/2013 to 6/3/2019.
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. Carl Zeiss Vision Sunlens Asia Pacific Ltd.'s FEI number is 3003344414.
What types of violations has Carl Zeiss Vision Sunlens Asia Pacific Ltd. received?
Carl Zeiss Vision Sunlens Asia Pacific 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 Carl Zeiss Vision Sunlens Asia Pacific Ltd. come from?
All FDA import refusal data for Carl Zeiss Vision Sunlens Asia Pacific 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.