# FDA 483 - Kedrion Biopharma Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/kedrion-biopharma-inc/4bb0d998-5d67-433f-9727-8746fe93caff

> FDA 483 for Kedrion Biopharma Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kedrion Biopharma Inc.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Kedrion BioPharma, Inc. in Melville, NY, a biologic manufacturer, revealed significant deficiencies in their production of RhoGAM. The firm failed to follow written production and process control procedures, inadequately investigated deviations, lacked established procedures for microbiological contamination control, and did not exercise appropriate data integrity controls over computer systems used for PPQ lots.

## Related Documents

- [483 - 2021-06-25](https://www.keypedia.com/records/483/kedrion-biopharma-inc/35995803-c3d0-4321-b6b6-3f34abdff6af)
- [483 - 2024-03-27](https://www.keypedia.com/records/483/kedrion-biopharma-inc/f9576627-ce90-4755-8c13-1b00e51568c4)

## Related Officers

- [Angela Chang, Regulatory Officer](https://www.keypedia.com/people/angela-chang-regulatory-officer/6d734c68-c19c-49ca-bfec-15574731ba40)
- [Farah Naz, Biologist](https://www.keypedia.com/people/farah-naz-biologist/6f25cb8f-73bd-4281-a485-2b2bcc7ac071)
- [Peter Gwin, CSO](https://www.keypedia.com/people/peter-gwin-cso/bc08a44a-b2a0-455e-a5c9-ad50e36da798)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd