FDA Inspection 743574 — MIRA, Inc.
The FDA completed an inspection of MIRA, Inc. on August 26, 2011 in Uxbridge, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 26, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Uxbridge, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3149 | 21 CFR 820.180 | Availability |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |