Premier Optical MFY. LTD.
⚠️ Moderate Risk
FEI: 3003098076 • Kowloon Bay • HONG KONG
FEI Number
3003098076
Location
Kowloon Bay
Country
HONG KONGAddress
Unit 917, 9 F, Metro Centre Ii; 21 Lam Hing Street, Kowloon Bay, , 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 IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/29/2004 | 86HQZFRAME, SPECTACLE | 235NOT IMPACT | Los Angeles District Office (LOS-DO) |
| 1/9/2004 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) | |
| 1/3/2004 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) | |
| 6/12/2003 | 86HQZFRAME, SPECTACLE | 235NOT IMPACT | Los Angeles District Office (LOS-DO) |
| 6/12/2003 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Los Angeles District Office (LOS-DO) |
| 6/12/2003 | 86HQZFRAME, SPECTACLE | 235NOT IMPACT | Los Angeles District Office (LOS-DO) |
| 4/15/2003 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Los Angeles District Office (LOS-DO) |
| 1/29/2003 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Seattle District Office (SEA-DO) |
| 6/24/2002 | 86HQZFRAME, SPECTACLE | 235NOT IMPACT | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Premier Optical MFY. LTD.'s FDA import refusal history?
Premier Optical MFY. LTD. (FEI: 3003098076) has 9 FDA import refusal record(s) in our database, spanning from 6/24/2002 to 1/29/2004.
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. Premier Optical MFY. LTD.'s FEI number is 3003098076.
What types of violations has Premier Optical MFY. LTD. received?
Premier Optical MFY. 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 Premier Optical MFY. LTD. come from?
All FDA import refusal data for Premier Optical MFY. 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.