FDA 483 - Calmo Manufacturing, Inc - August 23, 2019

Ca-Leo Manufacturing, Inc. in Huntington Beach, CA, was cited for significant deficiencies during an FDA inspection from August 19-23, 2019. The firm lacked essential written procedures for quality control unit responsibilities, deviation investigations, change control, and electronic data backup. Additionally, observations included failure to requalify stability chambers, inadequate oversight of contract laboratories, and issues with electronic record retention.