Rentschler Biopharma Inc. – FDA 483

Rentschler Biopharma Inc., a drug substance manufacturer in Milford, MA, was cited for nine observations during an FDA inspection. Key issues include inadequate investigations into discrepancies and microbial isolates, incomplete batch and master production records, and insufficient controls over laboratory methods, document issuance, equipment maintenance, and electronic data backup. The findings indicate significant concerns regarding quality control, data integrity, and facility maintenance.