483
Baxter Oncology GmbHBaxter Oncology GmbH – FDA 483, Aug 20, 2018
Record Details
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.
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ID · 44a76868-527b-4e97-8b39-bf984e859eb6
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