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1096634

Exela Pharma Sciences LLC — FEI 3008563008

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 18, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lenoir, NC (United States)

Facility

Other inspections at this facility

  • 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))
  • 1026858 (VAI Thu Sep 28 2017 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
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
186921 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures