483
Bajaj Medical, LLCFDA 483 - Bajaj Medical, LLC - December 04, 2024
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An FDA inspection of Bajaj Medical, LLC's Corporate Headquarters in Chicago, IL, revealed a significant deficiency in their quality system. The firm failed to develop written procedures for the surveillance, receipt, and evaluation of post-marketing adverse drug experiences. This indicates a critical gap in their ability to monitor and respond to potential safety issues with their products.
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ID · d2a595f2-54a6-4f20-b8c2-f1b96bd61e97