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1026858

Exela Pharma Sciences LLC — FEI 3008563008

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 28, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lenoir, NC (United States)

Facility

Other inspections at this facility

  • 1096634 (VAI Thu Jul 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081405 (NAI Wed Dec 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067755 (NAI Tue Sep 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988490 (NAI Wed Jun 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 906470 (VAI Fri Nov 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
154021 CFR 211.125(a)Strict control not exercised over labeling issued
172521 CFR 211.134(c)Examinations documented
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
18008FDCA 503B(a)(10)Drug product label, outsourcer facility