FDA 483 - IncludeHealth - November 01, 2023

IncludeHealth, a medical device manufacturer in Dublin, OH, was cited with five observations during an FDA inspection from October 24 to November 1, 2023. The inspection revealed significant deficiencies across its quality system, including inadequate software validation, CAPA procedures, complaint handling, quality audits, and management review processes. These issues indicate a broad lack of established and followed procedures for ensuring device quality and regulatory compliance.