FDA 483 - Tecomet, Inc. - April 18, 2024

Tecomet, Inc. in Boulder, CO, a medical device contract manufacturer, was cited for inadequate establishment and implementation of corrective and preventive action (CAPA) procedures. The inspection revealed failures in documenting investigative activities, linking corrective actions to root causes, and defining clear verification of effectiveness plans for various CAPA records. This indicates significant deficiencies in the firm's quality system regarding non-conformance resolution.