Rentschler Biopharma Inc. – FDA 483, Jan 17, 2025

Rentschler Biopharma Inc. in Milford, MA, a biologic drug substance manufacturer, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern severe data integrity issues, inadequate cleaning procedures for equipment and cleanroom materials, and failures in quality unit oversight and documentation of manufacturing activities. These issues indicate a lack of robust control over critical manufacturing and quality systems.