825863

Generitech Corporation — FEI 3002994577

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 5, 2013
Fiscal Year
2013
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Fresno, CA (United States)

Citations

IDCFRDescription
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
192621 CFR 211.166(b)Adequate number of batches on stability
241921 CFR 211.198(a)Complaint Handling Procedure
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
900121 CFR 211.22(a)Lack of quality control unit