FDA 483 - Diasol, Inc - June 28, 2021

The FDA inspected Diasol, Inc., a medical device manufacturer in Phoenix, AZ, from June 7-28, 2021. The inspection revealed significant deficiencies in the firm's quality system, including failures to document corrective and preventive actions, maintain device history records, perform quality audits, and conduct regular management reviews. These issues indicate a lack of control over critical quality processes.