FDA Inspection 1256988 — Dharma Research, Inc.
The FDA completed an inspection of Dharma Research, Inc. on December 11, 2024 in Miami, FL. 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
- December 11, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |