# FDA 483 - Baxalta US Incorporated - Unknown Date

Source: https://www.keypedia.com/records/483/baxalta-us-incorporated/2c9f53ea-4178-44bd-9dff-97e8db87c69b

> FDA 483 for Baxalta US Incorporated on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxalta US Incorporated
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Baxalta US Inc. in Los Angeles, CA, a blood fractionation manufacturing facility, identified two observations related to quality control. The firm failed to repeat environmental monitoring performance qualification studies and a washer study, despite these studies not meeting their predefined acceptance criteria. This indicates a deficiency in ensuring the validity and reliability of critical manufacturing processes.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/baxalta-us-incorporated/5a11597d-16c5-488c-a489-0a2229cf58f3)
- [483 - 2023-05-31](https://www.keypedia.com/records/483/baxalta-us-incorporated/5b7fa0e7-3cf6-4111-ba3b-e0ccea013a8f)

## Related Officers

- [Randa Melhem, PhD, CSO (Lead)](https://www.keypedia.com/people/randa-melhem-phd-cso-lead/3c7512dd-a400-4f5b-919c-426f054d1dab)
- [Zuben E. Sauna, Research Biologist](https://www.keypedia.com/people/zuben-e-sauna-research-biologist/6fe72300-e3c0-4dc7-9270-1a616888aedd)

Company: https://www.keypedia.com/companies/baxalta-us-incorporated/bb2b5b07-7c9c-4fce-b969-4dc5fa402b64

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4