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899290

Hill Dermaceuticals, Inc. — FEI 1036365

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 6, 2014
Fiscal Year
2015
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))
  • 794615 (OAI Fri Aug 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773876 (OAI Fri Mar 30 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
136121 CFR 211.100(a)Absence of Written Procedures
191221 CFR 211.166(a)Written program not followed
191821 CFR 211.166(a)(2)Stability sample storage conditions described
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
440221 CFR 211.192Written record of investigation incomplete
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications