483
scPharmaceuticals Inc.scPharmaceuticals Inc. – FDA 483, Jan 25, 2024
Record Details
During an inspection, scPharmaceuticals Inc. was cited for deficient procedures in handling written and oral complaints related to drug products. The firm failed to conduct adequate investigations into several adverse drug experiences concerning its Furoscix product, including instances of patient death, rash, burning sensations, and lack of efficacy. These failures indicate significant issues with the firm's quality system for post-market surveillance.
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ID · 29fa9aac-4e9e-41a7-8e08-b6ab8d03dcbe
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