1098500

Continental Manufacturing Chemist, Inc. — FEI 1910648

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 30, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Madrid, IA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
185121 CFR 211.84(e)Rejecting When Specifications Not Met
434221 CFR 211.142(b)Storage under appropriate conditions