1099164

Ernest Jackson & Co., Ltd. — FEI 3002806922

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 8, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Crediton (United Kingdom)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
178721 CFR 211.80(a)Procedures To Be in Writing
188521 CFR 211.165(b)Microbiological testing
354721 CFR 211.46(b)Equipment for Environmental Control
363121 CFR 211.170(b)Investigation of reserve sample deterioration