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680869

Hill Dermaceuticals, Inc. — FEI 1036365

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 10, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sanford, FL (United States)

Facility

Other inspections at this facility

  • 1287088 (VAI Tue Oct 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1149082 (VAI Wed Aug 11 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053606 (VAI Fri May 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 899290 (VAI Mon Oct 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 794615 (OAI Fri Aug 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
115921 CFR 211.28(a)Clothing appropriate for duties performed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
180921 CFR 211.160(a)Following/documenting laboratory controls
188321 CFR 211.165(a)Testing and release for distribution
192021 CFR 211.166(a)(3)Valid stability test methods
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
203421 CFR 211.194(d)Laboratory equipment calibration records
241921 CFR 211.198(a)Complaint Handling Procedure
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360221 CFR 211.160(a)Deviations from laboratory control requirements
360921 CFR 211.160(b)(2)In-process sample representation/identification
363221 CFR 211.170(b)Annual visual exams of drug products