FDA 483 - Tecomet, Inc. - April 18, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · c86fef30-6d69-4363-9381-587e9c1669f9