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

Source: https://www.globalkeysolutions.net/records/483/rentschler-biopharma-se/a356438e-6da6-487c-a025-d6d0b1b6c608

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

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## Details

- Record Type: 483
- Company Name: Rentschler Biopharma SE
- Inspection Date: 2023-03-07
- Office Name: Division of Biotechnology Manufacturing
- Summary: This FDA Form 483 details several observations regarding a firm's manufacturing processes and quality systems.

**Facility and Operations:** The firm operates GMP suites for upstream and downstream processing of drug substance intermediates and product samples, including a Point of Use (POU) for batching and product manufacturing. They also handle cell banks and utilize a REDACTED system for purification.

**Violations and Observations:**
1.  **Inadequate Microbial Contamination Prevention:** The firm continuously recovered endospore formers, objectionable microorganisms, and human isolates in GMP suites and product samples. Numerous deviations (e.g., DEV-2021-0027, 2022-0313, 2023-003) were raised between 2021-2023 for Bacillus spp., Paenibacillus glucanolyticus, Enterococcus spp., and human isolates. This led to batch REDACTED being rejected as "Not for Human Use" due to Bacillus spp. contamination (OOS-OOT-2021-0077, 2021-0080, 2021-0161, 0131).
2.  **Infrequent Endotoxin Monitoring:** The REDACTED POU (REDACTED) used for batching and product manufacturing is infrequently monitored for endotoxins. RL-SOP

## 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/a389d15c-79c7-4e86-8ab6-bab16b1db149)

## Related Officers

- [Caryn Mcnab](https://www.globalkeysolutions.net/people/caryn-mcnab/05d5f65d-5ab2-4798-a3a2-2798a82237e1)
- [Lead  Biologist](https://www.globalkeysolutions.net/people/leiyun-w-boone/454ce531-ae82-4ae4-9b3d-8e4e8afed127)
- [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-biotechnology-manufacturing/3e3018f1-aa48-4010-a554-96f557f17c55