FDA Inspection 919205 — AIDI Biomedical LLC
The FDA completed an inspection of AIDI Biomedical LLC on February 27, 2015 in Wildomar, 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
- February 27, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wildomar, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |