FDA Inspection 1116353 — BOX MEDICAL SOLUTIONS INC.
The FDA completed an inspection of BOX MEDICAL SOLUTIONS INC. on Jan 30, 2020 in Thousand Oaks, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 30, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Thousand Oaks, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |