FDA Inspection 1097561 — DB Diagnostic Systems Inc.
The FDA completed an inspection of DB Diagnostic Systems Inc. on Jul 16, 2019 in Juno Beach, FL. 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
- Jul 16, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Juno Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |