FDA 483 - Rio Biofarma Brasil Ltda - May 09, 2024

An FDA inspection of RIO BIOFARMA BRASIL LTDA in Hortolandia, Sao Paulo, a sterile drug manufacturer, revealed significant deficiencies in laboratory controls, process validation, and quality control procedures. The firm failed to establish adequate specifications, prevent microbiological contamination, thoroughly investigate discrepancies, and properly revalidate processes. These issues collectively indicate a serious lack of control over drug product identity, strength, quality, and purity.