FDA 483 - PharmaEssentia Corporation, Taichung Plant - September 21, 2023

An FDA inspection of PharmaEssentia Corporation's Drug Product and PEG Facility in Taichung, Taiwan, revealed significant deficiencies across multiple areas of sterile drug product manufacturing. The firm's visual inspection procedures, environmental controls, sterilization validation, and process monitoring were found to be inadequate. Additionally, issues with deviation investigations, data integrity, and incoming material release practices were identified, indicating a lack of robust quality control and assurance.