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

Source: https://www.keypedia.com/records/483/rentschler-biopharma-se/d478c0bf-7c00-4889-8637-c77375653c02

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

---

## Details

- Record Type: 483
- Company Name: Rentschler Biopharma SE
- Inspection Date: 2023-03-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Rentschler Biopharma SE, a drug substance intermediate manufacturer in Laupheim, Germany, was cited for significant deficiencies in microbial contamination control, quality unit oversight, and facility qualification. Observations included continuous recovery of objectionable microorganisms in GMP suites, misclassification of critical deviations, and unqualified cell bank transport systems. These issues indicate a lack of robust quality systems impacting product quality and control.

## Related Documents

- [483 - 2022-02-15](https://www.keypedia.com/records/483/rentschler-biopharma-se/3d74a8dd-3407-4ca5-8531-86e86b20f52c)
- [483 - 2022-02-15](https://www.keypedia.com/records/483/rentschler-biopharma-se/dd46571c-c83f-449f-a4c7-b1b10e214eae)
- [EIR - 2022-02-15](https://www.keypedia.com/records/eir/rentschler-biopharma-se/d3900ca0-3215-45e5-b136-19fb4ba548b9)
- [483 - 2023-03-07](https://www.keypedia.com/records/483/rentschler-biopharma-se/a389d15c-79c7-4e86-8ab6-bab16b1db149)
- [483 - 2023-03-07](https://www.keypedia.com/records/483/rentschler-biopharma-se/a356438e-6da6-487c-a025-d6d0b1b6c608)

## Related Officers

- [Wendy G. Tan](https://www.keypedia.com/people/wendy-g-tan/aad9c7d5-1a63-43b6-bc25-531b7f4475a9)
- [Caryn M. Mcnab](https://www.keypedia.com/people/caryn-m-mcnab/b91d70a6-ee59-4412-b0cf-77cce971c080)
- [Microbiologist](https://www.keypedia.com/people/wendy-tan/24f63b1c-33e5-440c-9853-2a18c141afa3)
- [Caryn Mcnab](https://www.keypedia.com/people/caryn-mcnab/05d5f65d-5ab2-4798-a3a2-2798a82237e1)
- [Lead  Biologist](https://www.keypedia.com/people/leiyun-w-boone/454ce531-ae82-4ae4-9b3d-8e4e8afed127)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8