FDA 483 - BIOPTIMAL INTERNATIONAL PTE. LTD. - November 09, 2023

An FDA inspection of BIOPTIMAL INTERNATIONAL PTE. LTD. in Singapore revealed significant deficiencies in their quality system for medical devices. The firm failed to adequately establish procedures for complaint handling, medical device reporting, corrective and preventive actions, and risk analysis. Additionally, issues were noted with sterilization process validation and device history records.