FDA 483 - Tetracore, Inc. - December 06, 2019

Tetracore, Inc. in Rockville, MD, a medical device manufacturer, was inspected by the FDA from December 3-6, 2019. The inspection revealed significant deficiencies in their quality system, including a lack of management review, inadequate equipment installation, absence of risk analysis, and poorly established procedures for corrective and preventive actions and quality audits. These findings indicate a systemic failure to maintain an effective quality system.