FDA 483 - Avanti Polar Lipids - July 07, 2023

During an inspection from July 5-7, 2023, Avanti Polar Lipids, an excipient manufacturer in Alabaster, AL, was cited for inadequate controls over computer systems. The firm's data integrity Standard Operating Procedures (SOPs) were found deficient, specifically lacking proper management of chromatography audit trails and user privileges, indicating significant concerns with data reliability.