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FDA Inspection 1202788 — Sharp Sterile Manufacturing, LLC

Sharp Sterile Manufacturing, LLC — FEI 3012144557

The FDA completed an inspection of Sharp Sterile Manufacturing, LLC on January 20, 2023 in Lee, MA. 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
January 20, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Lee, MA (United States)

Facility

Other inspections at this facility

  • 1305732 (OAI Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1240940 (VAI Wed Jun 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1216061 (VAI Fri Aug 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1155119 (VAI Fri Oct 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1132516 (OAI Tue Oct 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources