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1229051

Nephron SC, LLC — FEI 3010892830

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 9, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
West Columbia, SC (United States)

Facility

Other inspections at this facility

  • 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))
  • 1071620 (VAI Wed Nov 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
361321 CFR 211.160(b)(4)Establishment of calibration procedures