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1178224

Purdue Pharmaceuticals LP — FEI 3002960808

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 11, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Wilson, NC (United States)

Facility

Other inspections at this facility

  • 1113735 (VAI Thu Dec 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028417 (NAI Thu Aug 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 888629 (NAI Thu Jul 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 860931 (NAI Fri Nov 08 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 708668 (VAI Thu Jan 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
200921 CFR 211.188Prepared for each batch, include complete information
363221 CFR 211.170(b)Annual visual exams of drug products
435421 CFR 211.165(d)Acceptance/Rejection Levels
438121 CFR 211.198(b)(2)Written investigation record or copy kept at establishment