FDA 483 - KOFU FACTORY OF TERUMO CORP. - December 13, 2024

KOFU FACTORY OF TERUMO CORP. in Yamanashi, Japan, was inspected and found to have significant deficiencies in its sterile drug product manufacturing. The inspection revealed widespread issues including inadequate aseptic processing controls, environmental monitoring, visual inspection, data integrity, cleaning and sanitization, and overall quality unit oversight. These findings indicate a high severity of non-compliance with GMP regulations, posing a risk to product sterility and quality.