Starkey Laboratories Inc
⚠️ Moderate Risk
FEI: 3002111873 • Miramar, FL • UNITED STATES
FEI Number
3002111873
Location
Miramar, FL
Country
UNITED STATESAddress
3301 Executive Way, , Miramar, 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
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
Frequently Asked Questions
What is Starkey Laboratories Inc's FDA import refusal history?
Starkey Laboratories Inc (FEI: 3002111873) has 2 FDA import refusal record(s) in our database, spanning from 7/11/2005 to 7/11/2005.
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. Starkey Laboratories Inc's FEI number is 3002111873.
What types of violations has Starkey Laboratories Inc received?
Starkey Laboratories Inc 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 Starkey Laboratories Inc come from?
All FDA import refusal data for Starkey Laboratories 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.