FDA 483 - Katecho LLC - July 16, 2021

Katecho Inc. in Des Moines, IA, was inspected by the FDA, resulting in four observations related to quality system deficiencies. The inspection revealed issues with process validation, including inadequate standards and undocumented procedures, as well as failures in monitoring validated process parameters. Additionally, the firm had significant shortcomings in its corrective and preventive action (CAPA) documentation and its procedures for handling and evaluating customer complaints.