FDA 483 - EirGenix, Inc., Zhubei Branch - June 16, 2022

This FDA Form 483 report for EirGenix, Inc., Zhubei Branch, identifies significant deficiencies across its quality systems. The firm failed to adequately initiate, investigate, and document deviations and out-of-specification results, and lacked proper procedures for preventing cross-contamination in its multi-product facility. Additional issues include ineffective employee training, failures in Quality Unit responsibilities, inadequate analytical methods and equipment qualification, and insufficient monitoring of processes, facilities, and laboratory instruments, indicating a broad lack of control over critical operations.