# FDA 483 - Kedrion Biopharma Inc. - March 27, 2024

Source: https://www.keypedia.com/records/483/kedrion-biopharma-inc/f9576627-ce90-4755-8c13-1b00e51568c4

> FDA 483 for Kedrion Biopharma Inc. on March 27, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kedrion Biopharma Inc.
- Inspection Date: 2024-03-27
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Kedrion Biopharma, Inc. in Melville, NY, was inspected from March 20-27, 2024, and received a Form 483 with two observations. The inspection revealed issues with ineffective cleaning procedures for critical manufacturing equipment, leading to multiple temperature excursions in the fractionation department. Additionally, the firm failed to document deviations from batch production and control records, with numerous temperature excursions identified only after batch completion.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/kedrion-biopharma-inc/4bb0d998-5d67-433f-9727-8746fe93caff)
- [483 - 2021-06-25](https://www.keypedia.com/records/483/kedrion-biopharma-inc/35995803-c3d0-4321-b6b6-3f34abdff6af)

## Related Officers

- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.keypedia.com/companies/kedrion-biopharma-inc/e6cf606f-c996-4278-ad90-ec69fbd2a7f7

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