FDA 483 - Rentschler Biopharma SE - March 07, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Rentschler Biopharma SE, a drug substance intermediate manufacturer in Laupheim, Germany, was cited for significant deficiencies in microbial contamination control, quality unit oversight, and facility qualification. Observations included continuous recovery of objectionable microorganisms in GMP suites, misclassification of critical deviations, and unqualified cell bank transport systems. These issues indicate a lack of robust quality systems impacting product quality and control.
ID · d478c0bf-7c00-4889-8637-c77375653c02