Exactech, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to adequately establish procedures for corrective and preventive actions, as required under 21 CFR 820.100(a). Specifically,

Passage 2

Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection, your firm identified the document titled “Adverse Event Reporting to Regulatory Authorities”, SOP# 701-103-102, Revision W, dated 2/8/2023 as its written MDR procedure. After reviewing the procedure, the following deficiencies were noted:

Passage 3

Failure to submit a report to FDA no later than 30 calendar days after the day that your firm receives or otherwise become aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).