# FDA 483 - Rentschler Biopharma Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/rentschler-biopharma-inc/de95d6e5-df18-44ba-a408-3ae47c7a8886

> FDA 483 for Rentschler Biopharma Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rentschler Biopharma Inc.
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Baxalta US Inc. in Milford, MA, a drug substance manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate quality control procedures, incomplete investigations, poor record-keeping, and insufficient quality oversight. These issues indicate a systemic lack of control over critical manufacturing and testing processes.

## 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)
- [483 - 2025-01-17](https://www.keypedia.com/records/483/rentschler-biopharma-inc/0fe66179-4551-4180-ad52-673fd6891127)
- [EIR - 2025-01-17](https://www.keypedia.com/records/eir/rentschler-biopharma-inc/6e73238f-6472-418b-a935-878b9d720dbb)

## Related Officers

- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.keypedia.com/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)
- [Chava Kimchi Sarfaty](https://www.keypedia.com/people/chava-kimchi-sarfaty/c183423e-9344-4d76-8ef2-512a5fed80c1)

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