OrthoPediatrics CorpAugust 18, 2023

FDA 483 - OrthoPediatrics Corp - August 18, 2023

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Record Details

An FDA inspection of OrthoPediatrics Corp in Warsaw, IN, revealed significant deficiencies in the firm's complaint handling system. Procedures for receiving, reviewing, and evaluating complaints were not adequately established. Issues included product being lost or scrapped before evaluation, inadequate documentation of investigation information, and failure to determine root causes for multiple complaints.

Company: OrthoPediatrics Corp
Inspection Date: August 18, 2023
Product Type: Device
Office: Cincinnati District Office
Person: Shannon A. Gregory

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ID · 8e9be422-7c24-4bf3-aab9-252b57b9a02f