Baxter Oncology GmbHAugust 20, 2018

FDA 483 - Baxter Oncology GmbH - August 20, 2018

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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.

Company: Baxter Oncology GmbH
Inspection Date: August 20, 2018
Product Type: Drugs
Office: International Compliance Team
People: Luis M. Burgos
Emilie E. Kahn (Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality)

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ID · 44a76868-527b-4e97-8b39-bf984e859eb6