FDA 483 - Lambda Research, Inc. - August 26, 2022

An FDA inspection of Lambda Research Inc, a control testing laboratory in Cincinnati, OH, revealed significant deficiencies in their quality control unit's procedures and documentation. The firm failed to adequately review and document periodic proficiency testing for laboratory personnel performing X-ray diffraction analysis of pharmaceutical samples. Additionally, the quality unit lacked written procedures outlining the scope and frequency of Current Good Manufacturing Practice (CGMP) training for relevant personnel.