FDA Inspection 626993 — MIRA, Inc.
The FDA completed an inspection of MIRA, Inc. on November 5, 2009 in Uxbridge, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 5, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Uxbridge, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |