FDA 483 - Rentschler Biopharma Inc. - March 26, 2018

Baxalta US, Inc. in Milford, MA, a biological drug manufacturer, was cited for numerous significant deficiencies during an FDA inspection. Key issues include failures in thoroughly investigating out-of-specification results, inadequate process validation and change control, poor aseptic practices leading to potential contamination, and severe data integrity issues across electronic systems and documentation. The firm also failed to report serious adverse events and biological product deviations within required timelines.