FDA 483 - Takeda - September 25, 2019

An FDA inspection of Takeda's biologic drug manufacturing facility in Round Lake, IL, revealed significant deficiencies. The firm was cited for failing to minimize contamination risk during albumin bulk filling operations, evidenced by microbial exceedances. Additionally, Takeda's corrective actions were deemed ineffective in addressing recurring issues with leaking product bags, and the company failed to complete its required annual drug establishment registration.