# FDA 483 - Rentschler Biopharma SE - March 07, 2023

Source: https://www.globalkeysolutions.net/records/483/rentschler-biopharma-se/a389d15c-79c7-4e86-8ab6-bab16b1db149

> FDA 483 for Rentschler Biopharma SE on March 07, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rentschler Biopharma SE
- Inspection Date: 2023-03-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Rentschler Biopharma SE, a drug substance intermediate manufacturer in Laupheim, Germany, was cited for significant deficiencies during an FDA inspection. Observations included inadequate microbial contamination prevention, improper environmental monitoring practices, failures in quality unit responsibilities, and unqualified cell bank transport systems. These issues indicate a lack of robust quality control and risk management in critical manufacturing processes.

## Related Documents

- [483 - 2022-02-15](https://www.globalkeysolutions.net/records/483/rentschler-biopharma-se/dd46571c-c83f-449f-a4c7-b1b10e214eae)
- [EIR - 2022-02-15](https://www.globalkeysolutions.net/records/eir/rentschler-biopharma-se/d3900ca0-3215-45e5-b136-19fb4ba548b9)
- [483 - 2022-02-15](https://www.globalkeysolutions.net/records/483/rentschler-biopharma-se/3d74a8dd-3407-4ca5-8531-86e86b20f52c)
- [483 - 2023-03-07](https://www.globalkeysolutions.net/records/483/rentschler-biopharma-se/a356438e-6da6-487c-a025-d6d0b1b6c608)

## Related Officers

- [Caryn Mcnab](https://www.globalkeysolutions.net/people/caryn-mcnab/05d5f65d-5ab2-4798-a3a2-2798a82237e1)
- [Leiryn Boone](https://www.globalkeysolutions.net/people/leiryn-boone/be6ca3ec-68e0-41c6-a26b-09495fed0128)
- [Wendy G. Tan](https://www.globalkeysolutions.net/people/wendy-g-tan/aad9c7d5-1a63-43b6-bc25-531b7f4475a9)

Company: https://www.globalkeysolutions.net/companies/rentschler-biopharma-se/da50fa41-24f6-449f-bf90-45eccb97d9ba

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