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FDA Inspection 1239951 — Exactech, Inc.

Exactech, Inc. — FEI 1038671

The FDA completed an inspection of Exactech, Inc. on October 9, 2024 in Gainesville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 9, 2024
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Gainesville, FL (United States)

Facility

Other inspections at this facility

  • 1259482 (OAI Wed Aug 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1218918 (OAI Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1158246 (VAI Wed Nov 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1116804 (NAI Fri Jan 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019340 (NAI Fri Jul 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources