1071093

SC Johnson Professional USA, Inc. — FEI 3001606885

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 30, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Stanley, NC (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113621 CFR 211.25(c)Inadequate number of personnel
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
188321 CFR 211.165(a)Testing and release for distribution
197521 CFR 211.182Written records kept in individual logs
203121 CFR 211.194(a)Complete test data included in records
360221 CFR 211.160(a)Deviations from laboratory control requirements
432021 CFR 211.84(d)(6)Microbiological Contamination Exam