FDA 483 - Oxus, Inc. - October 10, 2019

Okul, Inc. in Auburn Hills, MI, a medical device establishment, was issued a Form FDA 483 following an inspection. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the establishment and implementation of corrective and preventive actions (CAPA) and the timely and adequate handling of product complaints. These issues indicate a lack of robust procedures and consistent execution for critical quality processes.