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 NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 27, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |