Orthopedic Specialty Institute
⚠️ Moderate Risk
FEI: 3005320903 • Orange, CA • UNITED STATES
FEI Number
3005320903
Location
Orange, CA
Country
UNITED STATESAddress
280 S Main St Ste 200, , Orange, CA, 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
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
Frequently Asked Questions
What is Orthopedic Specialty Institute's FDA import refusal history?
Orthopedic Specialty Institute (FEI: 3005320903) has 2 FDA import refusal record(s) in our database, spanning from 2/5/2009 to 2/5/2009.
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. Orthopedic Specialty Institute's FEI number is 3005320903.
What types of violations has Orthopedic Specialty Institute received?
Orthopedic Specialty Institute 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 Orthopedic Specialty Institute come from?
All FDA import refusal data for Orthopedic Specialty Institute 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.