FDA 483 - Tecomet Inc. - January 09, 2020

An FDA inspection of Tecomet Inc., a medical device manufacturer in Wilmington, MA, revealed significant deficiencies in their quality system. The firm lacked adequate procedures for controlling purchased products and services, failed to document finished device acceptance, and did not maintain proper personnel training records. These issues indicate a need for improved adherence to quality system regulations, particularly concerning supplier management, product release, and employee competency.