# FDA 483 - Aquestive Therapeutics - January 30, 2025

Source: https://www.globalkeysolutions.net/records/483/aquestive-therapeutics/986d4495-7f77-47ff-acec-d2c38ff0c2ab

> FDA 483 for Aquestive Therapeutics on January 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aquestive Therapeutics
- Inspection Date: 2025-01-30
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: An FDA inspection of Aquestive Therapeutics in Portage, Indiana, revealed two significant observations. The firm failed to thoroughly investigate product complaints, specifically regarding white spots on SUBOXONE® sublingual film, and lacked adequate corrective and preventive actions. Additionally, the company did not have sufficient systems in place to comply with the Drug Supply Chain Security Act's verification requirements for suspect and illegitimate products.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)

Company: https://www.globalkeysolutions.net/companies/aquestive-therapeutics/1f8e3576-370b-4aa2-b1d2-6d0faa6c3631

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03