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1098363

Fresenius Medical Care Holdings, Inc. — FEI 3001451489

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 2, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Waltham, MA (United States)

Facility

Other inspections at this facility

  • 1237243 (OAI Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1214802 (OAI Wed Aug 02 2023 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
1802621 CFR 314.80(f)(2)Incomplete ADE information on ICSR
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report