AptaPharma Inc.September 25, 2019

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.

Company: AptaPharma Inc.
Inspection Date: September 25, 2019
Product Type: Drugs
Office: New Jersey District Office
Person: Nancy M. Espinal (Investigator)

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