# FDA 483 - Ascent Pharmaceuticals Inc - October 13, 2020

Source: https://www.keypedia.com/records/483/ascent-pharmaceuticals-inc/b3e18f47-8ed5-4369-97a2-52cd5886bfa7

> FDA 483 for Ascent Pharmaceuticals Inc on October 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ascent Pharmaceuticals Inc
- Inspection Date: 2020-10-13
- 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 in data integrity, quality system procedures, and storage conditions. Observations included a lack of audit trail review for laboratory and manufacturing equipment, premature closure of change controls, and inadequate investigation and effectiveness checks for CAPAs. Additionally, drug product components were stored without proper humidity control.

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## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

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