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1071620

Nephron SC, LLC — FEI 3010892830

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 14, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
West Columbia, SC (United States)

Facility

Other inspections at this facility

  • 1229051 (OAI Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1167490 (OAI Wed Apr 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1168119 (OAI Wed Apr 20 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109980 (VAI Fri Nov 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099348 (NAI Fri Jun 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
145221 CFR 211.113(b)Validation lacking for sterile drug products
358521 CFR 211.110(a)Control procedures to monitor and validate performance