FDA 483 - Opto-Pharm Pte Ltd. - September 01, 2022

Opto-Pharm Pte Ltd. in Singapore, a sterile drug manufacturer, received a Form 483 with 14 observations highlighting significant deficiencies across its quality system, facilities, equipment, and laboratory controls. The inspection revealed widespread issues including inadequate nonconformance investigations, insufficient written procedures, lack of employee training, deficient environmental monitoring in aseptic areas, and poor building and equipment maintenance. These findings indicate a systemic failure to adhere to cGMP requirements, posing a risk to the quality and sterility of drug products.