MicroAire Surgical Instruments, LLC
⚠️ Moderate Risk
FEI: 2020601 • Charlottesville, VA • UNITED STATES
FEI Number
2020601
Location
Charlottesville, VA
Country
UNITED STATESAddress
3590 Grand Forks Blvd, , Charlottesville, VA, 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
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2023 | 79QPBSYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL | Division of Southeast Imports (DSEI) | |
| 4/25/2022 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 8/27/2014 | 68XYY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 9/11/2006 | 87HXYBRACE, DRILL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/11/2006 | 87HXYBRACE, DRILL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/11/2006 | 87HXYBRACE, DRILL | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MicroAire Surgical Instruments, LLC's FDA import refusal history?
MicroAire Surgical Instruments, LLC (FEI: 2020601) has 6 FDA import refusal record(s) in our database, spanning from 9/11/2006 to 12/15/2023.
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. MicroAire Surgical Instruments, LLC's FEI number is 2020601.
What types of violations has MicroAire Surgical Instruments, LLC received?
MicroAire Surgical Instruments, LLC has been cited for 4 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 MicroAire Surgical Instruments, LLC come from?
All FDA import refusal data for MicroAire Surgical Instruments, 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.