# FDA 483 - Rentschler Biopharma Inc. - January 17, 2025

Source: https://www.keypedia.com/records/483/rentschler-biopharma-inc/0fe66179-4551-4180-ad52-673fd6891127

> FDA 483 for Rentschler Biopharma Inc. on January 17, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rentschler Biopharma Inc.
- Inspection Date: 2025-01-17
- Product Type: biologics
- Office Name: New England District Office
- Summary: Rentschler Biopharma Inc. in Milford, MA, a biologic drug substance manufacturer, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern severe data integrity issues, inadequate cleaning procedures for equipment and cleanroom materials, and failures in quality unit oversight and documentation of manufacturing activities. These issues indicate a lack of robust control over critical manufacturing and quality systems.

## Related Documents

- [EIR - 2019-12-13](https://www.keypedia.com/records/eir/rentschler-biopharma-inc/3306cffb-7bc4-435a-83a0-112dd6797561)
- [483 - Unknown Date](https://www.keypedia.com/records/483/rentschler-biopharma-inc/cea16de9-51b2-4829-9c14-fa8be6f2a0e0)
- [483 - 2023-03-22](https://www.keypedia.com/records/483/rentschler-biopharma-inc/f192f328-ac15-4dfa-b0a3-6360dc6ce911)
- [EIR - 2025-01-17](https://www.keypedia.com/records/eir/rentschler-biopharma-inc/6e73238f-6472-418b-a935-878b9d720dbb)

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [Vivek Jumani](https://www.keypedia.com/people/vivek-jumani/a376992c-ac4c-40b6-ad63-163d726d5ce4)
- [investigator](https://www.keypedia.com/people/divek-r-jumani/ba9b28e9-d9b3-4c9f-8532-25f037ff7ce4)

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

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144