707147

Topical Pharmaceuticals, Inc. — FEI 3005402103

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 18, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Addison, IL (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
202721 CFR 211.192Investigations of discrepancies, failures
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
430621 CFR 211.80(a)Written Procedures Not Followed