# FDA 483 - Ascent Pharmaceuticals Inc - September 15, 2022

Source: https://www.keypedia.com/records/483/ascent-pharmaceuticals-inc/2e23b981-2208-442a-b00c-5dea4a7b4772

> FDA 483 for Ascent Pharmaceuticals Inc on September 15, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ascent Pharmaceuticals Inc
- Inspection Date: 2022-09-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Ascent Pharmaceuticals Inc's corporate headquarters in Central Islip, NY, revealed a significant lapse in their Risk Evaluation and Mitigation Strategy (REMS) program. The firm failed to maintain its approved REMS Implementation System by not providing required REMS-specific links on its product website to the official REMS Program website. This indicates a failure to comply with post-market requirements for their opioid analgesic products.

## Related Documents

- [EIR - 2018-02-21](https://www.keypedia.com/records/eir/ascent-pharmaceuticals-inc/08fb764b-023a-4f94-b7fa-d8d8c7e29daf)
- [EIR - 2018-11-07](https://www.keypedia.com/records/eir/ascent-pharmaceuticals-inc/bf03bde7-3589-4d60-bff6-b421b9fbb1b2)
- [483 - 2020-10-13](https://www.keypedia.com/records/483/ascent-pharmaceuticals-inc/b3e18f47-8ed5-4369-97a2-52cd5886bfa7)
- [EIR - 2020-10-13](https://www.keypedia.com/records/eir/ascent-pharmaceuticals-inc/3eaf2db1-5d5f-47da-9d2e-06c2a5c8b70b)
- [EIR - 2022-09-15](https://www.keypedia.com/records/eir/ascent-pharmaceuticals-inc/2fb010b3-445b-435d-a436-65bc3ad95991)

## Related Officers

- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

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