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1158246

Exactech, Inc. — FEI 1038671

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 17, 2021
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: 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))
  • 1239951 (VAI Wed Oct 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1218918 (OAI Tue Sep 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1116804 (VAI 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

Citations

IDCFRDescription
1471921 CFR 820.30(h)Incorrect translation to production specifications
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
326321 CFR 820.250(b)Sampling plans
54621 CFR 820.75(a)Lack of or inadequate process validation