Company
United StatesMicroAire Surgical Instruments, LLC, Charlottesville, VA – FDA Inspections
Inspection records and compliance data for MicroAire Surgical Instruments, LLC in Charlottesville, Virginia. 3 FDA inspections on record (1 OAI), 1 warning letter, last inspected March 17, 2016.
Company Profile
This profile covers MicroAire Surgical Instruments, LLC based in Charlottesville, Virginia, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected March 31, 2011. Last inspected March 17, 2016.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Lack of or inadequate process validation2 inspections
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 17, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 964808 |
| August 22, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 892318 |
| March 31, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 716626 |
FDA documents
Warning Letters (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
MicroAire Surgical Instruments, LLC
FEI Number
2020601
Address
3590 Grand Forks Blvd, Charlottesville, Virginia 22911, United States
Country
United States
ID: 0640425a-8cad-48cc-96ff-d921c4a1e331