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# Rentschler Biopharma Germany Site 483
- URL: https://www.fdaweb.com/rentschler-biopharma-germany-site-483/
- Published: 2023-05-03T12:00:00.000Z
- Updated: 2026-09-14T18:29:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154357

FDA has issued a five-item [Form FDA-483](https://www.fda.gov/media/167789/download?ref=fdaweb.com) after a 2/27-3/7 inspection of Rentschler Biopharma’s manufacturing facility in Baden-Wurttemberg, Germany found significant GMP deficiencies. For example, the inspection cited the firm’s procedures for preventing microbial contamination as being inadequate. Inspectors said the facility continuously recovered endospore formers, objectionable microorganisms, and human isolates in GMP suites that are used for upstream and downstream processing certain drug substance intermediates and product samples.

The 483 also cited the firm’s use of environmental monitoring culture plates, and it said responsibilities of the quality unit are not always fully followed.” Additionally, it said cell bank transport systems for internal transfers are not qualified. “Specifically, no qualification data are available to support the cell bank handover procedure from the storage location to inoculum suite,” it says.

A 2/2022 inspection at Rentschler Biopharma’s German drug substance manufacturing plant resulted in a [nine-item FDA-483](https://www.fda.gov/media/159164/download?ref=fdaweb.com) that cited significant GMP violations. For example, FDA said the fill process is not controlled to an established specification. It also found the firm’s laboratory procedures for testing to assure compliance with established specifications and standards was not available. Additionally, equipment and facility systems in support of manufacturing have not been adequately validated, the inspection found, and Rentschler failed to establish an adequate system for monitoring environmental conditions for critical process equipment.