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1115467

Hospira, Inc. — FEI 1925262

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 17, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mcpherson, KS (United States)

Facility

Other inspections at this facility

  • 1255699 (VAI Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229140 (NAI Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064827 (OAI Wed Aug 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031233 (VAI Fri Oct 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976095 (OAI Wed Jun 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
135821 CFR 211.100(b)SOPs not followed / documented
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
2129521 CFR 211.110(b)In-process conformity - examination, sample testing
355021 CFR 211.46(c)Exhaust systems inadequate to control air contamination
358521 CFR 211.110(a)Control procedures to monitor and validate performance
361621 CFR 211.165(d)Acceptance criteria for sampling & testing
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
440221 CFR 211.192Written record of investigation incomplete