FDA 483 - Adamson Analytical Laboratories, Inc. - March 23, 2021

Adamson Analytical Laboratories, Inc. in Corona, CA, was cited for significant deficiencies in its analytical laboratory operations. The inspection revealed widespread issues with method validation, computer system controls, quality unit oversight of records and investigations, and change control procedures. These findings indicate a severe lack of control over critical laboratory processes impacting the quality and integrity of drug product testing.