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589456

Accupac, LLC — FEI 2518467

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 22, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mainland, PA (United States)

Facility

Other inspections at this facility

  • 1196516 (NAI Tue Jan 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030873 (VAI Thu Nov 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986007 (VAI Thu Mar 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844740 (VAI Fri Jul 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
135821 CFR 211.100(b)SOPs not followed / documented
197821 CFR 211.182Personnel dating/signing equipment log
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
430321 CFR 211.67(b)Written procedures fail to include