1053606

Hill Dermaceuticals, Inc. — FEI 1036365

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 18, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sanford, FL (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
188321 CFR 211.165(a)Testing and release for distribution
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
203421 CFR 211.194(d)Laboratory equipment calibration records
356521 CFR 211.58Buildings not maintained in good state of repair