FDA 483 - Ataia, Inc - March 07, 2022

Ataia, Inc., a medical device manufacturer in Silver Spring, MD, was inspected and cited for significant deficiencies in its quality system. The inspection revealed issues with the design history file for its SPEAX Communication System, including inadequate design input/output, unvalidated software, and uncontrolled design changes. Additionally, the firm failed to validate software used in production and its quality system, including electronic record storage and final inspection processes.