# FDA 483 - AptaPharma Inc. - March 16, 2018

Source: https://www.globalkeysolutions.net/records/483/aptapharma-inc/b8e498cb-6750-4e19-b7cd-a3cd4a19c5e5

> FDA 483 for AptaPharma Inc. on March 16, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AptaPharma Inc.
- Inspection Date: 2018-03-16
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Apta Pharma, Inc. in Pennsauken, New Jersey, received a Form FDA 483 citing four observations related to deficiencies in their laboratory, quality, and material systems. The inspection revealed issues including incomplete laboratory records for reference standards, inadequate process validation, and a lack of a robust drug product recall system with unapproved labeling. Additionally, the firm was cited for insufficient controls over electronic data, which allowed for the alteration of analytical records.

## Related Documents

- [EIR - 2018-03-16](https://www.globalkeysolutions.net/records/eir/aptapharma-inc/1dda210d-9101-42ce-aca7-33184b05f30e)
- [483 - 2019-09-25](https://www.globalkeysolutions.net/records/483/aptapharma-inc/bee3d493-6ce7-4c04-8af5-2007f5919b47)
- [483 - 2023-05-15](https://www.globalkeysolutions.net/records/483/aptapharma-inc/c030fb89-e748-43a8-a12b-56e31d0a48aa)

## Related Officers

- [Advisor](https://www.globalkeysolutions.net/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)

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

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