1147970

Waterlab Corporation — FEI 3016467001

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 30, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Salem, OR (United States)

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
239921 CFR 211.194(a)(2)Laboratory Test Method Verification
360321 CFR 211.160(b)Scientifically sound laboratory controls
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
441321 CFR 211.194(a)(8)Second person sign off