New York Optical Intl, Inc.
⚠️ Moderate Risk
FEI: 3000719430 • Davie, FL • UNITED STATES
FEI Number
3000719430
Location
Davie, FL
Country
UNITED STATESAddress
12960 W State Road 84, , Davie, FL, United States
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/6/2012 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/16/2011 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 12/13/2007 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is New York Optical Intl, Inc.'s FDA import refusal history?
New York Optical Intl, Inc. (FEI: 3000719430) has 4 FDA import refusal record(s) in our database, spanning from 12/13/2007 to 1/6/2012.
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. New York Optical Intl, Inc.'s FEI number is 3000719430.
What types of violations has New York Optical Intl, Inc. received?
New York Optical Intl, Inc. has been cited for 2 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 New York Optical Intl, Inc. come from?
All FDA import refusal data for New York Optical Intl, Inc. 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.