FDA Inspection 708197 — Micro Detect, Inc.
The FDA completed an inspection of Micro Detect, Inc. on Jan 19, 2011 in Tustin, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 19, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tustin, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |