FDA Inspection 1085891 — InfoBionic, Inc.
The FDA completed an inspection of InfoBionic, Inc. on April 10, 2019 in Chelmsford, MA. 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
- April 10, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chelmsford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 3696 | 21 CFR 820.100(b) | Documentation |