FDA 483 - Tenacore Holdings, Inc - March 11, 2021

An FDA inspection of Tenacore Holdings, Inc., a medical device manufacturer in Santa Ana, CA, revealed that the firm's procedures for Corrective and Preventive Action (CAPA) were not adequately established. Specifically, several CAPA records from 2019 remained open, lacking evidence of validation and verification for the effectiveness of corrective and preventive actions. This indicates a significant deficiency in the firm's quality system regarding CAPA implementation.