FDA 483 - Microchem Laboratory - April 30, 2026

An FDA inspection of Microchem Laboratory in Richardson, TX, from April 27-30, 2026, revealed significant deficiencies in the firm's quality management system and laboratory controls. The quality unit failed to adequately oversee qualification protocols and out-of-specification investigations, lacking proper documentation and scientific rationale. Additionally, laboratory controls were found to be deficient, with issues in method verification, validation, accuracy studies, and the absence of stability-indicating analytical methods.