Sooil Development Co., Ltd. – FDA Warning Letter, Jan 23, 2020

On April 16, 2020, the FDA issued a Warning Letter to SOOIL Development Co., Ltd. following an inspection from January 20-23, 2020, at their Gyeonggi-do, Republic of Korea facility, which manufactures the DANA Diabecare IIs insulin pump. The inspection found the devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include: 1. **CAPA (21 CFR 820.100(b)):** Inadequate documentation of corrective and preventive actions, specifically regarding root cause investigation for a missing code in traceability. 2. **Environmental Control (21 CFR 820.70(c)):** Failure to establish adequate procedures for controlling environmental conditions, such as radiated electromagnetic fields during manufacturing. 3. **Calibration (21 CFR 820.72(b)):** Inadequate calibration procedures, lacking requirements for retrospective review or