FDA 483 - Rio Biofarma Brasil Ltda - August 02, 2022

An FDA inspection of RIO BIOFARMA BRASIL LTDA, a sterile drug manufacturer in Hortolandia, Brazil, revealed significant deficiencies in aseptic processing controls and quality unit oversight. The firm failed to implement adequate environmental monitoring during sterile operations and did not properly review raw data from chromatography systems. Additionally, laboratory records lacked specifications, leading to unreported out-of-specification results for stability studies.