FDA Inspection 1099868 — Zerigo Health, Inc

Zerigo Health, Inc — FEI 3013229265

The FDA completed an inspection of Zerigo Health, Inc on August 19, 2019 in San Diego, 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
August 19, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
San Diego, CA (United States)

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures