AMANDA TURNER
⚠️ Moderate Risk
FEI: 3030566120 • Austin, TX • UNITED STATES
FEI Number
3030566120
Location
Austin, TX
Country
UNITED STATESAddress
801 W 38th St, , Austin, TX, 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/2/2024 | 86HNRFORCEPS, OPHTHALMIC | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is AMANDA TURNER's FDA import refusal history?
AMANDA TURNER (FEI: 3030566120) has 1 FDA import refusal record(s) in our database, spanning from 4/2/2024 to 4/2/2024.
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. AMANDA TURNER's FEI number is 3030566120.
What types of violations has AMANDA TURNER received?
AMANDA TURNER 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 AMANDA TURNER come from?
All FDA import refusal data for AMANDA TURNER 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.