FDA Inspection 971056 — BioCardia, Inc.

BioCardia, Inc. — FEI 3003610571

The FDA completed an inspection of BioCardia, Inc. on March 4, 2016 in Sunnyvale, CA. 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
March 4, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Sunnyvale, CA (United States)

Citations

IDCFRDescription
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ