FDA Inspection 1156962 — MIRA, Inc.
The FDA completed an inspection of MIRA, Inc. on November 18, 2021 in Uxbridge, MA. 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
- November 18, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Uxbridge, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |