FDA Inspection 859270 — Guidemia Technologies Inc.
The FDA completed an inspection of Guidemia Technologies Inc. on Dec 12, 2013 in Los Alamitos, 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Los Alamitos, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4189 | 21 CFR 820.198(a) | General |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 636 | 21 CFR 803.17(b)(2) | Reports and information documentation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |