FDA 483 - Roche Singapore Technical Operations Pte. Ltd. - August 01, 2022

Roche Singapore Technical Operations Pte. Ltd. in Singapore was inspected by the FDA, revealing significant deficiencies in manufacturing controls for drug substances. The inspection identified issues with equipment cleaning validation, material segregation, root cause investigations, production procedures, data integrity, and facility design. These observations indicate a moderate level of severity, impacting the quality and purity of drug substances.