FDA Inspection 1099803 — Spatz FGIA, Inc

Spatz FGIA, Inc — FEI 3015409025

The FDA completed an inspection of Spatz FGIA, Inc on August 9, 2019 in Ra'Anana. 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 9, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Ra'Anana (Israel)

Additional Details

Sponsor, Contract Research Organization

Citations

IDCFRDescription
292821 CFR 812.40Sponsors' general responsibilities