483
Baxter Healthcare SAFDA 483 - Baxter Healthcare SA - December 13, 2024
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Record Details
An FDA inspection of Baxter Healthcare SA in Singapore revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate unexplained discrepancies, product complaints, and out-of-specification results. Additionally, inadequate laboratory controls for environmental monitoring and microbial identification, along with a failure to follow written procedures for component storage and handling, were observed.
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ID · 375ca287-ee65-4b58-bd8b-69db4c9328fb