FDA EIR - InTheSmart Co., Ltd. - February 12, 2019

An FDA Establishment Inspection of InTheSmart Co., Ltd., a medical device manufacturer in Seoul, South Korea, was conducted from February 11-12, 2019. This Level II QSIT inspection, under the "Inspection of Medical Device Manufacturers" framework, focused on Design Controls, CAPA, Management Controls, and Production and Process Controls. Although no FDA Form 483 was issued, six significant deficiencies were discussed with management. Key issues included the improper labeling of devices sold for investigational use, the absence of defined acceptable tolerance ranges for calibrated measuring instruments, and an inadequate quarantine procedure for nonconforming products, leading to potential mix-ups. Additionally, the firm's risk analysis process showed inaccuracies in risk mitigation (reducing severity instead of probability) and undefined risk ranges. The Medical Device Report (MDR) procedure lacked specific FDA reporting requirements and timeframes, and there were discrepancies in sampling plans for raw material acceptance. The company committed to addressing these observations, including establishing a dedicated quarantine area, as it prepares for future commercial manufacturing and anticipates 510(k) approval for its fluorescent laparoscope device.