Home / Inspections / 1167657

1167657

Fagron Compounding Services — FEI 3012104093

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 24, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Wichita, KS (United States)

Facility

Other inspections at this facility

  • 1244425 (OAI Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093689 (OAI Fri Jun 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987526 (OAI Wed Sep 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
143521 CFR 211.42(c)(10)(v)Cleaning System
181021 CFR 211.160(a)Lab controls established, including changes
188321 CFR 211.165(a)Testing and release for distribution
358321 CFR 211.110(a)Written in-process control procedures