# FDA 483 - Rentschler Biopharma SE - February 15, 2022

Source: https://www.keypedia.com/records/483/rentschler-biopharma-se/3d74a8dd-3407-4ca5-8531-86e86b20f52c

> FDA 483 for Rentschler Biopharma SE on February 15, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rentschler Biopharma SE
- Inspection Date: 2022-02-15
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: This 483 report for Rentschler Biopharma SE in Laupheim, Germany, details significant deficiencies in manufacturing controls and quality systems for drug substance production. Observations include inadequate process validation, lack of control over critical equipment and materials, and failures in maintaining facility cleanliness and procedural compliance. The findings indicate a broad range of issues that could impact product quality and integrity.

## Related Documents

- [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/a356438e-6da6-487c-a025-d6d0b1b6c608)
- [483 - 2023-03-07](https://www.keypedia.com/records/483/rentschler-biopharma-se/a389d15c-79c7-4e86-8ab6-bab16b1db149)

## Related Officers

- [Ralph M. Bernstein](https://www.keypedia.com/people/ralph-m-bernstein/72173dfb-24ae-42a1-af9e-1dc7da02ed87)
- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

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

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