483
OrthoPediatrics CorpOrthoPediatrics Corp – FDA 483, Aug 18, 2023
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.
- Person
View Company Profile
ID · 8e9be422-7c24-4bf3-aab9-252b57b9a02f
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.