Company
United StatesMicroAire Surgical Instruments, LLC - Inspection Records
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
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 31, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Documents (7)
FDA Inspection 964808 - MicroAire Surgical Instruments, LLC - 2016-03-17
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FDA Inspection 964808 - MicroAire Surgical Instruments, LLC - 2016-03-17
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WARNING_LETTER - MicroAire Surgical Instruments, LLC - 2014-08-22
WARNING_LETTER
FDA Inspection 892318 - MicroAire Surgical Instruments, LLC - 2014-08-22
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FDA Inspection 892318 - MicroAire Surgical Instruments, LLC - 2014-08-22
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FDA Inspection 716626 - MicroAire Surgical Instruments, LLC - 2011-03-31
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FDA Inspection 716626 - MicroAire Surgical Instruments, LLC - 2011-03-31
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Name
MicroAire Surgical Instruments, LLC
FEI Number
2020601
State
Virginia
City
Charlottesville
ID: 0640425a-8cad-48cc-96ff-d921c4a1e331