FDA 483 - Katecho LLC - December 02, 2021

Katecho Inc., a contract manufacturer in Des Moines, IA, was cited for significant deficiencies in its quality system related to medical device manufacturing. The inspection revealed inadequate documentation of process validation activities, including justifications for single-lot validation and high reject rates, and a failure to properly establish process control procedures for microbiologic specifications. Additionally, the firm lacked proper documentation for rework activities and procedures for controlling non-conforming products, including investigations into test failures.