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Talk to a SpecialistTalk to a SpecialistAccu Bio-Chem Laboratories, a contract testing laboratory, was cited for significant Current Good Manufacturing Practice (CGMP) violations related to finished pharmaceutical drugs. FDA inspectors found that the company failed to conduct adequate investigations of out-of-specification (OOS) test results, instead preparing and testing new samples without first determining root causes—a practice lacking scientific justification. The firm's standard operating procedure for OOS investigations lacked appropriate instructions to identify the underlying causes of failed results, rendering the tested drug products adulterated under federal law.