Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistAdamson Analytical Laboratories, a contract testing laboratory for prescription and over-the-counter drugs and active pharmaceutical ingredients, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their drugs adulterated. The primary violation involved inadequate controls over gas chromatography data acquisition systems, which failed to prevent deletion or alteration of raw data files and granted inappropriate administrative privileges to laboratory personnel performing drug analyses. Additionally, the firm lacked sufficient controls over computer systems to prevent unauthorized changes to master production and control records. The company's April 2021 response to the FDA's inspection findings was deemed inadequate due to insufficient detail and evidence of corrective actions needed to achieve compliance.