# FDA 483 - Rentschler Biopharma Inc. - March 22, 2023

Source: https://www.keypedia.com/records/483/rentschler-biopharma-inc/f192f328-ac15-4dfa-b0a3-6360dc6ce911

> FDA 483 for Rentschler Biopharma Inc. on March 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rentschler Biopharma Inc.
- Inspection Date: 2023-03-22
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Rentchler Biopharma Inc. in Milford, MA, a drug substance manufacturer, was cited for significant deficiencies across multiple areas during an FDA inspection. Observations included inadequate microbial contamination prevention, poor data integrity practices, widespread procedural deficiencies, untimely deviation management, and inadequate computerized system access controls. These issues indicate a systemic lack of control over critical manufacturing and quality 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 - 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

- [Charles Luan-Chia Kuo, Staff Fellow](https://www.keypedia.com/people/charles-luan-chia-kuo-staff-fellow/038269f6-aa8e-46f1-bb93-a5e1ae277d6e)
- [Wendy Tan, PhD, Microbiologist](https://www.keypedia.com/people/wendy-tan-phd-microbiologist/24f63b1c-33e5-440c-9853-2a18c141afa3)
- [Yuan-Chia Kuo](https://www.keypedia.com/people/yuan-chia-kuo/35ef21f6-5de8-4fc7-a319-5d5666a4fb62)
- [Lead  Biologist](https://www.keypedia.com/people/leiyun-w-boone/454ce531-ae82-4ae4-9b3d-8e4e8afed127)
- [Leiyun Boone, PhD, Pharmaceutical Scientist](https://www.keypedia.com/people/leiyun-boone-phd-pharmaceutical-scientist/a048aa86-e6b7-47a0-92e7-8b94b7a4640f)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd