FDA 483 - Rentschler Biopharma SE - February 15, 2022

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.