FDA Inspection 674769 — MIRA, Inc.
The FDA completed an inspection of MIRA, Inc. on July 21, 2010 in Uxbridge, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 23 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 21, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Uxbridge, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3218 | 21 CFR 820.70(c) | Environmental control system-documentation/review inspection |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3414 | 21 CFR 820.200(d)(6) | Test and inspection data |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 3837 | 21 CFR 820.25(b) | Training records |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |