FDA Inspection 861126 — S4optik LLC

S4optik LLC — FEI 3004441848

The FDA completed an inspection of S4optik LLC on January 6, 2014 in Brentwood, MO. 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
January 6, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Brentwood, MO (United States)

Citations

IDCFRDescription
230221 CFR 820.20(e)Quality System Procedures