# FDA 483 - American Regent, Inc. - April 24, 2024

Source: https://www.globalkeysolutions.net/records/483/american-regent-inc/e05af8d5-5840-41a3-883d-b986d0f27bee

> FDA 483 for American Regent, Inc. on April 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Regent, Inc.
- Inspection Date: 2024-04-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: American Regent, Inc., a sterile drug manufacturer in Shirley, NY, was cited with seven observations during an FDA inspection. Deficiencies include inadequate aseptic processing air supply and environmental monitoring, inappropriate equipment design, and insufficient validation of aseptic processes. Additionally, the firm lacked proper computer system controls, failed to store drug products under appropriate temperature conditions, and had inadequate procedures for container closure integrity.

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Investigator](https://www.globalkeysolutions.net/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

Company: https://www.globalkeysolutions.net/companies/american-regent-inc/a73360d0-4ea2-40a4-aa12-221cece9173f

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