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FDA Inspection 1155650 — Par Health USA, LLC

Par Health USA, LLC — FEI 1818977

The FDA completed an inspection of Par Health USA, LLC on October 22, 2021 in Rochester, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 22, 2021
Fiscal Year
2022
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Rochester, MI (United States)

Facility

Other inspections at this facility

  • 1287690 (OAI Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1202528 (VAI Fri Apr 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086628 (VAI Mon Apr 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061939 (VAI Thu Aug 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007400 (VAI Mon Mar 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources