FDA 483 - Apotek Production & Laboratorier AB - January 29, 2026

An FDA inspection of Apotek Production & Laboratorier AB, a sterile drug manufacturer, revealed significant deficiencies across multiple areas of its quality system. Issues included inadequate validation of aseptic processes, poor aseptic techniques by operators, and a deficient environmental monitoring system. Further concerns were raised regarding incomplete batch records, unsuitable equipment design, lack of data integrity controls for laboratory equipment, and unvalidated laboratory test procedures, all impacting the assurance of sterile drug product quality.