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# FDA Hits Rentschler Biopharma with 9-item 483
- URL: https://www.fdaweb.com/fda-hits-rentschler-biopharma-with-9-item-483/
- Published: 2022-06-13T12:00:00.000Z
- Updated: 2026-09-14T17:48:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152048

A February inspection at Rentschler Biopharma’s German drug substance manufacturing plant has resulted in a [nine-item FDA-483](https://www.fda.gov/media/159142/download?ref=fdaweb.com) that cites 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.