UNIQUE SURGICAL, LLC
⚠️ Moderate Risk
FEI: 3009662572 • Fort Wayne, IN • UNITED STATES
FEI Number
3009662572
Location
Fort Wayne, IN
Country
UNITED STATESAddress
6435 W Jefferson Blvd # 242, , Fort Wayne, IN, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 5/23/2024 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Division of Southeast Imports (DSEI) | |
| 5/23/2024 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Division of Southeast Imports (DSEI) | |
| 5/23/2024 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is UNIQUE SURGICAL, LLC's FDA import refusal history?
UNIQUE SURGICAL, LLC (FEI: 3009662572) has 3 FDA import refusal record(s) in our database, spanning from 5/23/2024 to 5/23/2024.
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. UNIQUE SURGICAL, LLC's FEI number is 3009662572.
What types of violations has UNIQUE SURGICAL, LLC received?
UNIQUE SURGICAL, LLC has been cited for 3 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 UNIQUE SURGICAL, LLC come from?
All FDA import refusal data for UNIQUE SURGICAL, LLC 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.