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1030873

Accupac, LLC — FEI 2518467

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 2, 2017
Fiscal Year
2018
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))
  • 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))
  • 589456 (VAI Fri May 22 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
108621 CFR 211.22(b)Adequate lab facilities not available
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
122321 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
126321 CFR 211.68(b)Computer control of master formula records
356521 CFR 211.58Buildings not maintained in good state of repair