FDA Inspection 1097561 — DB Diagnostic Systems Inc.
The FDA completed an inspection of DB Diagnostic Systems Inc. on July 16, 2019 in Juno Beach, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 16, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |