FDA 483 - Vision Science Co., Ltd. - November 16, 2023

An FDA inspection of Vision Science Co., Ltd., a Class II medical device manufacturer located in Dong, Daegu, Korea, was conducted from November 13 to November 16, 2023. The inspection identified several significant observations concerning the firm's quality system, as detailed in this FDA Form 483. The primary issues observed relate to inadequate procedures for corrective and preventive actions (CAPA). Specifically, the firm's CAPA standard operating procedure (SOP) lacks explicit requirements for re-training as a corrective measure and fails to mandate specific timeframes for effectiveness checks, as evidenced by multiple closed CAPAs. Furthermore, critical manufacturing equipment, used for soft color contact lens packaging, did not meet specified requirements. The company could not provide documentation for seasonal controls during the equipment's initial qualification in 2016 or for particle measurement monitoring over the last two years, despite relevant cleanroom control guidelines. Finally, the firm lacked established procedures for device history records (DHRs). There was no defined guidance on the required documentation for DHRs, such as manufacturing dates, quantities, acceptance records, or primary identification labels. An audit of a specific DHR lot confirmed the absence of necessary labeling information. These observations highlight deficiencies in Vision Science Co., Ltd.'s adherence to quality system regulations, requiring the company to implement comprehensive corrective actions to address each identified concern and ensure compliance with FDA requirements.