FDA Inspection 716626 — MicroAire Surgical Instruments, LLC
The FDA completed an inspection of MicroAire Surgical Instruments, LLC on March 31, 2011 in Charlottesville, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 31, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlottesville, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |