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

PharmaEssentia Corporation"s drug product and PEG facility in Taichung, Taiwan, was inspected by the FDA between September 13 and September 21, 2023. The inspection resulted in nine observations detailing significant deficiencies in quality control and manufacturing safety. Key issues included inadequate visual inspection procedures that failed to investigate atypical trends like foreign particles and container defects. The facility"s airflow testing was incomplete, and staff demonstrated poor aseptic techniques, such as inadequate gloving practices and failure to monitor environmental conditions during equipment setup. Furthermore, the FDA found that the company lacked proper sterilization validation, failed to establish endotoxin limits for specific formulations, and did not adequately investigate manufacturing deviations like broken or missing components. Concerns were also raised regarding data integrity, as electronic files were not sufficiently protected from unauthorized access, and raw materials were released for production before final quality testing was completed. These findings indicate a systemic lack of robust process controls and environmental monitoring. While these observations do not represent a final determination of non-compliance, PharmaEssentia is required to provide a written response to the FDA. This response must detail the company"s planned corrective actions to address the identified gaps in their quality systems and manufacturing processes.