# FDA 483 - Aspire Pharmaceuticals, Inc. - July 14, 2023

Source: https://www.globalkeysolutions.net/records/483/aspire-pharmaceuticals-inc/3555efdc-e370-4c60-b0e5-f6af5ce805e3

> FDA 483 for Aspire Pharmaceuticals, Inc. on July 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aspire Pharmaceuticals, Inc.
- Inspection Date: 2023-07-14
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Aspire Pharmaceuticals, Inc. in Somerset, NJ, an OTC drug manufacturer, received a Form 483 for significant deficiencies in laboratory controls. The inspection revealed a failure to conduct required impurity testing for numerous batches of acetaminophen-containing OTC drug products and other OTC drug products, and a lack of established impurity specifications. This is a repeat observation from a previous FDA inspection and warning letter, indicating a persistent and serious compliance issue.

## Related Documents

- [483 - 2022-02-03](https://www.globalkeysolutions.net/records/483/aspire-pharmaceuticals-inc/5465bf77-219c-4d38-aa04-2a733ccc1ced)
- [WARNING_LETTER - 2022-02-03](https://www.globalkeysolutions.net/records/warning_letter/aspire-pharmaceuticals-inc/284cae70-c02e-4779-9230-c63438bab435)

## Related Officers

- [Charlotte P. Chang](https://www.globalkeysolutions.net/people/charlotte-p-chang/7d343ab4-c26e-430a-b1b6-d0d9f153b70e)
- [investigator](https://www.globalkeysolutions.net/people/jessica-m-monteiro/6147f61b-8b3f-4a30-872a-03b784897116)
- [Robin P. Mathew](https://www.globalkeysolutions.net/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)
- [Annet R. Rajan](https://www.globalkeysolutions.net/people/annet-r-rajan/81b5a458-094f-48a5-839d-5c47b1a7c259)

Company: https://www.globalkeysolutions.net/companies/aspire-pharmaceuticals-inc/a7f24f44-bab7-47c1-afe8-82174268bc8b

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