FDA 483 - Opto-Pharm Pte Ltd. - January 25, 2019

Opto-Pharm Pte Ltd. received a Form 483 citing significant deficiencies across its manufacturing and quality control operations for sterile drug products. Key issues include inadequate aseptic process validation, environmental monitoring, and laboratory controls for sterility testing and particulate matter. The firm also demonstrated poor data integrity practices, insufficient equipment cleaning validation, and a lack of adherence to written procedures for quality control, maintenance, and annual product reviews.