FDA WARNING_LETTER - Philosys Co. Ltd - August 30, 2018

On January 14, 2020, the FDA issued a Warning Letter to Mr. In Hwan Choi, regarding an inspection of his firm in Gunsan-si, Korea, from August 27-30, 2018. The firm manufactures Self-Monitoring Blood Glucose (SMBG) test systems, which are medical devices. The inspection revealed these devices are misbranded under 21 U.S.C. § 352(t)(2) due to failures in Medical Device Reporting (MDR) as required by 21 U.S.C. § 360i and 21 CFR Part 803.

Key violations include: 1. **Failure to submit timely MDRs:** The firm failed to report a serious injury (hypoglycemia due to false high glucose readings from a Gmate VOICE system) within 30 days, as required by 21 CFR 803.50(a)(1). A draft MDR (K113636-2015-00001) was noted, but FDA had not received it. The firm's response was inadequate, lacking evidence of systemic corrective actions, including a retrospective review of adverse events. An English translation of the corresponding complaint file (CS15-0420-01) was also requested. 2. **Failure to maintain MDR decision-