# FDA 483 - Baxalta US Incorporated - May 31, 2023

Source: https://www.keypedia.com/records/483/baxalta-us-incorporated/5b7fa0e7-3cf6-4111-ba3b-e0ccea013a8f

> FDA 483 for Baxalta US Incorporated on May 31, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxalta US Incorporated
- Inspection Date: 2023-05-31
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Baxalta US Inc. (Takeda) in Los Angeles, CA, a licensed biological products manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight severe issues in manufacturing deviation and OOS investigations, inadequate documentation practices, unsanitary facility conditions, and critical failures in QC microbiology testing and product labeling. These issues indicate a broad lack of control over product quality and safety.

## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6