Houston Eye Associates
✅ Low Risk
FEI: 3005246916 • Houston, TX • UNITED STATES
FEI Number
3005246916
Location
Houston, TX
Country
UNITED STATESAddress
2855 Gramercy St, , Houston, TX, United States
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/3/2006 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Houston Eye Associates's FDA import refusal history?
Houston Eye Associates (FEI: 3005246916) has 1 FDA import refusal record(s) in our database, spanning from 8/3/2006 to 8/3/2006.
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. Houston Eye Associates's FEI number is 3005246916.
What types of violations has Houston Eye Associates received?
Houston Eye Associates has been cited for 1 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 Houston Eye Associates come from?
All FDA import refusal data for Houston Eye Associates 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.