FDA 483 - Fujian Genohope Biotech Ltd - May 25, 2023

Fujian Genohope Biotech Ltd, a sterile drug manufacturer, received an FDA Form 483 following an inspection from May 25 to June 2, 2023. The inspection revealed multiple significant deviations from current Good Manufacturing Practices (GMP).Key issues included deficiencies in the Materials System, where the company failed to follow written procedures. Specifically, validation batches were manufactured using components that had already expired, without documented justification or risk assessment for these short-dated materials.Within the Facilities and Equipment System, critical equipment, such as an integrity tester, was used for product validation without proper qualification. Additionally, integrity test parameters were not consistently met, and electronic data generated by the SCADA system lacked adequate accuracy checks, with some data transferred via uncontrolled USB and incomplete backup documentation.The Production System also presented several concerns. Written procedures for production and process controls were found to be inadequate; for example, visual inspection procedures lacked defect classification and clear investigation criteria. Visual inspector qualifications were deficient, and appropriate lighting conditions for critical tasks like microbiology plate reading and retain sample review were not established. Furthermore, the company failed to adhere to its own written procedures, with observations including unauthorized USB access for data, modifiable system dates on critical equipment, operators not following visual inspection times, and un-gowned personnel in production areas. Equipment was also found to be improperly identified during batch production.These observations highlight the need for Fujian Genohope Biotech Ltd to implement comprehensive corrective and preventive actions, including updating and adhering to written procedures, qualifying equipment, strengthening data integrity controls, and ensuring proper training and gowning for personnel, to ensure the identity, strength, purity, and quality of their drug products.