483
Noven Pharmaceuticals IncNoven Pharmaceuticals Inc – FDA 483, Aug 24, 2026
Record Details
Noven Pharmaceuticals, Inc. in Miami, FL, received a Form 483 with four observations related to quality control and data integrity during an inspection. The firm failed to perform in-house identity testing for drug product components and lacked proper controls for electronic data backup and access. Additionally, issues included insufficient second-person verification for laboratory records and inadequate controls over alarm setpoint changes in a critical system.
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ID · 39396e04-3150-4a1e-86ba-253fe80be8b2
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