FDA Inspection 1206900 — Asahi Intecc Usa Inc
The FDA completed an inspection of Asahi Intecc Usa Inc on June 1, 2023 in Tustin, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 1, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tustin, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |