Exactech, Inc. – FDA Inspection, Mar 10, 2017

Record Details

This FDA Inspection record concerns Exactech, Inc., with an inspection on March 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: Exactech, Inc.
Inspection Date: March 10, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Richard K. Vogel (FDA Associated Person)

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ID · ea2faabf-3ba6-4de3-8037-f6197f1fd11e

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1005008
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate

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Other FDA inspections of Exactech, Inc.

Date	Classification	Office	Project area
August 27, 2025	OAI	Florida District Office	Compliance: Medical Devices
October 9, 2024	Not classified	Florida District Office
September 26, 2023	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
November 17, 2021	VAI	Center for Devices and Radiological Health	Compliance: Devices
January 31, 2020	VAI	Center for Devices and Radiological Health	Compliance: Devices