FDA 483 - Rentschler Biopharma Inc. - December 10, 2025

Rentschler Biopharma Inc., a drug substance manufacturer in Milford, MA, received a Form 483 with three observations. Issues included inadequate laboratory controls for analytical methods, insufficient quality review processes for validated spreadsheets leading to calculation errors, and poor organization of retention samples hindering traceability. These observations indicate significant deficiencies in quality control and data integrity.