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1237243

Fresenius Medical Care Holdings, Inc. — FEI 3001451489

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 16, 2024
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Waltham, MA (United States)

Facility

Other inspections at this facility

  • 1214802 (OAI Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098363 (NAI Fri Aug 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1037657 (VAI Fri Jan 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940091 (NAI Fri Aug 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 817769 (VAI Thu Feb 21 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements