# AptaPharma Inc. – FDA 483, Aug 14, 2026

Source: https://www.keypedia.com/records/483/aptapharma-inc/d630bef8-08ce-40ca-b11b-e88a45de5726

> FDA 483 for AptaPharma Inc. on August 14, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AptaPharma Inc.
- Inspection Date: 2026-08-14
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: AptaPharma Inc. in Pennsauken, NJ, a contract manufacturer, was cited with two observations during an FDA inspection. The firm's stability program for drug products lacked specific test methods, leading to unsupported shelf life extensions for multiple liquid OTC products without adequate microbial testing. Additionally, laboratory controls were found deficient, as the firm used expired reference standards for analytical testing, compromising the validity of results.

## Related Documents

- [483 - 2023-05-15](https://www.keypedia.com/records/483/aptapharma-inc/c030fb89-e748-43a8-a12b-56e31d0a48aa) — date: May 15, 2023
- [EIR - 2019-09-25](https://www.keypedia.com/records/eir/aptapharma-inc/d18cefab-62ca-482a-a0ab-82aa612dd019) — date: September 25, 2019
- [483 - 2019-09-25](https://www.keypedia.com/records/483/aptapharma-inc/bee3d493-6ce7-4c04-8af5-2007f5919b47) — date: September 25, 2019
- [483 - 2018-03-16](https://www.keypedia.com/records/483/aptapharma-inc/b8e498cb-6750-4e19-b7cd-a3cd4a19c5e5) — date: March 16, 2018
- [EIR - 2018-03-16](https://www.keypedia.com/records/eir/aptapharma-inc/1dda210d-9101-42ce-aca7-33184b05f30e) — date: March 16, 2018

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/michael-o-idowu/795647ab-8f6b-47cc-ae88-3b2c61192861)

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