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985003

Woodbine Products Company Inc. — FEI 1519202

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 6, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Medina, OH (United States)

Facility

Other inspections at this facility

  • 1179797 (VAI Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 749084 (NAI Thu Oct 20 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 636524 (NAI Wed Dec 16 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
136121 CFR 211.100(a)Absence of Written Procedures
180121 CFR 211.84(a)Components withheld from use pending release
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
900121 CFR 211.22(a)Lack of quality control unit