941356

Oasis Medical, Inc. — FEI 2083373

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 28, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Glendora, CA (United States)

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
189021 CFR 211.165(e)Test methods
194221 CFR 211.180(e)Records reviewed annually
197521 CFR 211.182Written records kept in individual logs
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance