# FDA 483 - Aquestive Therapeutics Inc. - October 07, 2021

Source: https://www.keypedia.com/records/483/aquestive-therapeutics-inc/8a5c02ec-4264-46b0-a064-c4c2c3bd734a

> FDA 483 for Aquestive Therapeutics Inc. on October 07, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aquestive Therapeutics Inc.
- Inspection Date: 2021-10-07
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Aquestive Therapeutics Inc. revealed significant deficiencies in their post-marketing adverse drug experience reporting system. The firm lacked complete written procedures for surveillance, receipt, evaluation, and reporting of adverse drug experiences. Additionally, the company failed to submit several required periodic and annual reports in a timely manner for their approved drug applications, indicating systemic issues with pharmacovigilance compliance.

## Related Documents

- [EIR - 2021-10-07](https://www.keypedia.com/records/eir/aquestive-therapeutics-inc/cef21864-817e-4986-937d-cbdab9b377cf)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/aquestive-therapeutics-inc/1e41e1b8-9082-47bb-a232-b1b554b36f8a)

## Related Officers

- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)
- [Shirley S. Wen](https://www.keypedia.com/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)

Company: https://www.keypedia.com/companies/aquestive-therapeutics-inc/0af9c6f6-1dab-4856-8cfc-33d5fe99b717

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