FDA 483 - Cognita Labs LLC - December 13, 2023

Cognita Labs LLC, a medical device manufacturer in Santa Ana, CA, was inspected by the FDA from December 7-13, 2023. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the establishment of adequate procedures for device history records and the disposition of nonconforming products. These issues indicate a lack of proper documentation and control over manufacturing processes and product quality.