# FDA 483 - Rentschler Biopharma Inc. - March 26, 2018

Source: https://www.keypedia.com/records/483/rentschler-biopharma-inc/da3845bf-1c47-4d06-8ae7-e9be7f70c57e

> FDA 483 for Rentschler Biopharma Inc. on March 26, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rentschler Biopharma Inc.
- Inspection Date: 2018-03-26
- Product Type: biologics
- Office Name: Office of Partnerships
- Summary: Baxalta US, Inc. in Milford, MA, a biological drug manufacturer, was cited for numerous significant deficiencies during an FDA inspection. Key issues include failures in thoroughly investigating out-of-specification results, inadequate process validation and change control, poor aseptic practices leading to potential contamination, and severe data integrity issues across electronic systems and documentation. The firm also failed to report serious adverse events and biological product deviations within required timelines.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/rentschler-biopharma-inc/de95d6e5-df18-44ba-a408-3ae47c7a8886)
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- [483 - 2025-01-17](https://www.keypedia.com/records/483/rentschler-biopharma-inc/0fe66179-4551-4180-ad52-673fd6891127)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/arie-c-menachem/01bacbef-a3ae-4eb0-a56f-e8a70b67a524)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Investigator](https://www.keypedia.com/people/alice-silva/b4b46db5-2b1a-452c-a403-9265a8785330)

Company: https://www.keypedia.com/companies/rentschler-biopharma-inc/5ef7256a-aef2-44ce-a792-80c28829c138

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3