# FDA 483 - Kedrion Biopharma Inc. - June 25, 2021

Source: https://www.keypedia.com/records/483/kedrion-biopharma-inc/35995803-c3d0-4321-b6b6-3f34abdff6af

> FDA 483 for Kedrion Biopharma Inc. on June 25, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kedrion Biopharma Inc.
- Inspection Date: 2021-06-25
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Medisca Biopharma Inc. in Melville, NY, an API and Intermediate Manufacturer, revealed significant deficiencies in facility cleanliness and process control. Inspectors observed powdery substances and dried matter on equipment labeled as "clean," indicating inadequate cleaning practices. Furthermore, there was no current assessment of the cleaning process, including microbial control, which could impact product quality.

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## Related Officers

- [David Galler-Veezy](https://www.keypedia.com/people/david-galler-veezy/205be5dc-84fa-4744-8262-8ebfe693c26e)
- [investigator](https://www.keypedia.com/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [company_representative](https://www.keypedia.com/people/c-eric-thomas/563f7441-9424-4c78-953a-5cf7c3484b24)
- [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