# FDA 483 - AptaPharma Inc. - September 25, 2019

Source: https://www.keypedia.com/records/483/aptapharma-inc/bee3d493-6ce7-4c04-8af5-2007f5919b47

> FDA 483 for AptaPharma Inc. on September 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AptaPharma Inc.
- Inspection Date: 2019-09-25
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Documents

- [EIR - 2018-03-16](https://www.keypedia.com/records/eir/aptapharma-inc/1dda210d-9101-42ce-aca7-33184b05f30e)
- [483 - 2018-03-16](https://www.keypedia.com/records/483/aptapharma-inc/b8e498cb-6750-4e19-b7cd-a3cd4a19c5e5)
- [483 - 2023-05-15](https://www.keypedia.com/records/483/aptapharma-inc/c030fb89-e748-43a8-a12b-56e31d0a48aa)

## Related Officers

- [Investigator](https://www.keypedia.com/people/nancy-m-espinal/f4494790-6a37-4998-853c-f859a0eb3330)

Company: https://www.keypedia.com/companies/aptapharma-inc/8390ea00-697d-4f5d-9e50-407830a6b2ee

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248