FDA 483 - Rio Biofarma Brasil Ltda - August 02, 2022
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.
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.
ID · a3ce097d-3d9c-47f5-bb8d-02d6db0b5081