DiamoDent, Inc. – FDA 483, Nov 4, 2021

DiamoDent, Inc. in Anaheim, CA, a medical device manufacturer, was inspected by the FDA from November 1-4, 2021. The inspection revealed significant deficiencies in quality system procedures, including unvalidated production software, undocumented management reviews, and issues with internal quality audits where the auditor had direct responsibility for the matters being audited and audits were not consistently performed or documented. These findings indicate a lack of adherence to established quality system requirements.