# FDA 483 - Baxalta US Inc. - April 07, 2022

Source: https://www.globalkeysolutions.net/records/483/baxalta-us-inc/45fd3851-40ed-446c-8ca0-05c8cd0ca027

> FDA 483 for Baxalta US Inc. on April 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxalta US Inc.
- Inspection Date: 2022-04-07
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Baxalta US Inc. in Thousand Oaks, CA, identified significant deficiencies in their manufacturing processes for sterile drug products. The firm's aseptic process validations, specifically media fills, were found to be inadequate, failing to accurately simulate commercial production conditions and interventions. Additionally, investigations into unexplained discrepancies and batch failures were insufficient, often not extending to other affected batches or being closed in a timely manner.

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## Related Officers

- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)
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- [issuing_officer](https://www.globalkeysolutions.net/people/omotunde-osunsanmi/41c6ef66-1d5c-4940-8b1f-628da20cde34)

Company: https://www.globalkeysolutions.net/companies/baxalta-us-inc/dd00e45b-9175-4b17-82d5-b189a034a97f

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