# FDA 483 - Ascent Pharmaceuticals Inc - August 09, 2024

Source: https://www.keypedia.com/records/483/ascent-pharmaceuticals-inc/b4c3eb9d-fc43-485b-92aa-b15585f5b691

> FDA 483 for Ascent Pharmaceuticals Inc on August 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ascent Pharmaceuticals Inc
- Inspection Date: 2024-08-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Ascent Pharmaceuticals Inc. in Central Islip, NY, was inspected and cited for significant deficiencies across multiple areas of its drug manufacturing operations. Observations included inadequate cleaning of equipment, insufficient computer system controls and audit trail reviews, lack of routine equipment performance checks, and a failure to investigate unexplained batch discrepancies. These issues indicate a lack of control over manufacturing processes and data integrity.

## Related Documents

- [483 - 2020-10-13](https://www.keypedia.com/records/483/ascent-pharmaceuticals-inc/b3e18f47-8ed5-4369-97a2-52cd5886bfa7)
- [483 - 2022-09-15](https://www.keypedia.com/records/483/ascent-pharmaceuticals-inc/2e23b981-2208-442a-b00c-5dea4a7b4772)

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Austin M Marium](https://www.keypedia.com/people/austin-m-marium/39d34f84-6246-4cbd-a438-a00dfa748732)
- [Raihan A. Chowdhury](https://www.keypedia.com/people/raihan-a-chowdhury/739813d5-2f9b-4048-91c7-911fd595f8d3)
- [Wei Yang](https://www.keypedia.com/people/wei-yang/b56f1d24-d9d2-4009-bd2c-8d50b9d850ea)
- [Luxuly Abraham](https://www.keypedia.com/people/luxuly-abraham/d33e3164-ec89-488b-bab9-a9ec30544970)

Company: https://www.keypedia.com/companies/ascent-pharmaceuticals-inc/a6df28ee-9e4e-4fae-8eed-dbe5eb870593

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961