FDA Inspection 1096287 — Iowa Adaptive Technologies Inc.
The FDA completed an inspection of Iowa Adaptive Technologies Inc. on July 11, 2019 in Coralville, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 11, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Coralville, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |