FDA Inspection 941392 — Banyan Medical, LLC
The FDA completed an inspection of Banyan Medical, LLC on August 24, 2015 in Warwick, RI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 24, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Warwick, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |