FDA Inspection 675121 — Minaris Medical America, Inc.
The FDA completed an inspection of Minaris Medical America, Inc. on August 6, 2010 in Mountain View, CA. 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
- August 6, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mountain View, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |