483
InvaGen Pharmaceuticals, Inc.InvaGen Pharmaceuticals, Inc. – FDA 483, Jul 17, 2026
Record Details
DoveGen Pharmaceuticals, Inc. in Central Islip, NY, a manufacturer and packager, was cited for failing to establish sufficient systems and processes to comply with the Drug Supply Chain Security Act (DSCSA). The inspection revealed deficiencies in their procedures for identifying and investigating suspect products, responding to illegitimate product notifications, and notifying relevant parties. This indicates a significant gap in their drug supply chain security protocols.
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ID · e2345939-67d8-4074-9a86-ab1550cc29d5
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