# Rentschler Biopharma Inc. – FDA 483

Source: https://www.keypedia.com/records/483/rentschler-biopharma-inc/cea16de9-51b2-4829-9c14-fa8be6f2a0e0

> 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: Division of Northeast Imports 
- Summary: Rentschler Biopharma Inc., a drug substance manufacturer in Milford, MA, was cited for nine observations during an FDA inspection. Key issues include inadequate investigations into discrepancies and microbial isolates, incomplete batch and master production records, and insufficient controls over laboratory methods, document issuance, equipment maintenance, and electronic data backup. The findings indicate significant concerns regarding quality control, data integrity, and facility maintenance.

## Related Documents

- [483 - 2025-12-10](https://www.keypedia.com/records/483/rentschler-biopharma-inc/d5119927-8e86-4a25-b5ee-5a23c1d26602) — date: December 10, 2025
- [EIR - 2025-01-17](https://www.keypedia.com/records/eir/rentschler-biopharma-inc/6e73238f-6472-418b-a935-878b9d720dbb) — date: January 17, 2025
- [483 - 2025-01-17](https://www.keypedia.com/records/483/rentschler-biopharma-inc/0fe66179-4551-4180-ad52-673fd6891127) — date: January 17, 2025
- [483 - 2023-03-22](https://www.keypedia.com/records/483/rentschler-biopharma-inc/f192f328-ac15-4dfa-b0a3-6360dc6ce911) — date: March 22, 2023
- [EIR - 2019-12-13](https://www.keypedia.com/records/eir/rentschler-biopharma-inc/3306cffb-7bc4-435a-83a0-112dd6797561) — date: December 13, 2019

## Related Officers

- [investigator](https://www.keypedia.com/people/janet-l-bowen/be89d94b-a945-4c6e-8981-fb11f750bbe8)
- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.keypedia.com/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94