FDA 483 - Cranial Technologies Inc - May 13, 2025

Cranial Technologies Inc. in Tempe, AZ, was inspected and received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in quality system procedures, including inadequate software validation, lost complaint files, and poorly established procedures for quality audits, corrective and preventive actions, and management reviews. These issues indicate a systemic breakdown in maintaining a compliant quality system for their Doc Band cranial orthotic device.