FDA Inspection 1027029 — Banyan Medical, LLC

Banyan Medical, LLC — FEI 3009770724

The FDA completed an inspection of Banyan Medical, LLC on September 29, 2017 in Warwick, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 29, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Warwick, RI (United States)

Citations

IDCFRDescription
326621 CFR 820.86Acceptance status