FDA 483 - Clinical Resolution Laboratory Inc. - January 16, 2025

Clinical Resolution Laboratory Inc. in Brea, CA, a drug manufacturer, was cited with five observations during an FDA inspection from January 7-16, 2025. The inspection revealed significant deficiencies primarily related to quality control, including inadequate investigations into out-of-specification results, insufficient component testing, and issues with water system design. Additionally, the firm's batch production and control records were found to be deficient and inconsistent with master records and process validation.