Home / Inspections / 815426

815426

Fresenius Kabi USA, LLC — FEI 3001833549

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 11, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Grand Island, NY (United States)

Facility

Other inspections at this facility

  • 1220482 (VAI Fri Oct 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1216357 (NAI Wed Aug 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099323 (VAI Mon Aug 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014707 (VAI Thu Mar 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002820 (VAI Wed Feb 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
439021 CFR 211.180(c)Photocopying of records not allowed
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
891221 CFR 314.81(b)(2)Timely submission