483
AptaPharma Inc.FDA 483 - AptaPharma Inc. - September 25, 2019
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Record Details
Aptapharma Inc. in Pennsauken, NJ, was cited during a pre-approval inspection for two significant issues. The firm failed to follow established specifications for dissolution testing, including issues with test methods and specification updates. Additionally, the inspection revealed a lack of adequate and qualified equipment necessary for commercial manufacturing of drug products.
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ID · bee3d493-6ce7-4c04-8af5-2007f5919b47