# Kedrion Biopharma Inc. – FDA 483, May 21, 2026

Source: https://www.keypedia.com/records/483/kedrion-biopharma-inc/6164a421-e5b9-4c0d-aee9-616ecb1fd220

> FDA 483 for Kedrion Biopharma Inc. on May 21, 2026. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kedrion Biopharma Inc.
- Inspection Date: 2026-05-21
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Kedrion Biopharma Inc. in Melville, NY, a manufacturer of Source Plasma derivatives, received an FDA Form 483 with eight observations highlighting significant deficiencies. Issues included ineffective equipment cleaning, inaccurate batch records, inadequate equipment identification, and failures in laboratory control mechanisms. The inspection also found problems with inventory control, environmental monitoring alarms, trending of in-process data, and a lack of pre-approval supplement submission for a process change.

## Related Documents

- [483 - 2024-03-27](https://www.keypedia.com/records/483/kedrion-biopharma-inc/f9576627-ce90-4755-8c13-1b00e51568c4) — date: March 27, 2024
- [483 - 2021-06-25](https://www.keypedia.com/records/483/kedrion-biopharma-inc/35995803-c3d0-4321-b6b6-3f34abdff6af) — date: June 25, 2021
- [483](https://www.keypedia.com/records/483/kedrion-biopharma-inc/4bb0d998-5d67-433f-9727-8746fe93caff)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [issuing_officer](https://www.keypedia.com/people/malgorzata-g-norton/ba7b8827-0976-4abd-8abb-95d4222d2bdc)
- [Lu Deng](https://www.keypedia.com/people/lu-deng/2d16f326-f067-4b7b-a8bd-d22f87281972)

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