FDA 483 - Baxter Oncology GmbH - August 20, 2018

Baxter Oncology GmbH received a Form 483 with four observations related to manufacturing process control and quality systems. The firm's process validation was found deficient, leading to commercial lots failing specifications, and critical manufacturing equipment was not properly qualified. Additionally, batch production records lacked necessary documentation, and the quality control unit failed to adhere to its stability monitoring program.