FDA 483 - Adamson Analytical Laboratories, Inc. - October 04, 2022

An FDA inspection of Adamson Analytical Laboratories, Inc. in Corona, CA, revealed significant deficiencies across multiple areas of their laboratory operations. The firm failed to properly validate test methods and analytical instruments, often implementing procedures and performing testing without necessary approvals or completed qualifications. Additionally, the quality control unit's responsibilities and procedures were not consistently followed or implemented in a timely manner, and employees lacked adequate training on current standard operating procedures.