# FDA 483 - Rentschler Biopharma Inc. - December 10, 2025

Source: https://www.keypedia.com/records/483/rentschler-biopharma-inc/d5119927-8e86-4a25-b5ee-5a23c1d26602

> FDA 483 for Rentschler Biopharma Inc. on December 10, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rentschler Biopharma Inc.
- Inspection Date: 2025-12-10
- Product Type: drugs
- Office Name: New England District Office
- Summary: Rentschler Biopharma Inc., a drug substance manufacturer in Milford, MA, received a Form 483 with three observations. Issues included inadequate laboratory controls for analytical methods, insufficient quality review processes for validated spreadsheets leading to calculation errors, and poor organization of retention samples hindering traceability. These observations indicate significant deficiencies in quality control and data integrity.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/rentschler-biopharma-inc/de95d6e5-df18-44ba-a408-3ae47c7a8886)
- [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)

## Related Officers

- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

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