FDA 483 - The Ritedose Corporation - February 28, 2025

The Ritedose Corporation, a sterile drug manufacturer, received an FDA Form 483 citing significant deficiencies in facility maintenance, aseptic process validation, and discrepancy investigations. Observations included insanitary conditions and structural damage in cleanrooms, inadequate airflow visualization studies for sterile drug production, and a failure to thoroughly investigate critical pressure excursions. These issues indicate a potential for product contamination and a lack of robust quality control.