Beijing KES Biology Technology Co., Ltd. – FDA Warning Letter, Mar 20, 2015

On July 23, 2015, the FDA issued a Warning Letter to Beijing KES Biology Technology Co., Ltd. following an inspection from March 16-20, 2015. The inspection revealed that the firm's intense pulsed light (IPL) systems are 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 comply with Medical Device Reporting (MDR) requirements (21 CFR Part 803).

Key violations include: 1. **Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d))**: MED-210 devices exceeded energy density limits, and the finished device testing procedure (b)(4) was inadequate, lacking details for pulse interval, energy detection calculation, cooling system settings, and not describing all tests on form (b)(4). The firm's response was deemed inadequate as it lacked clarity on increased monitoring and description of inspection items. 2. **Failure to establish and maintain procedures for verifying device design (21 CFR 820.30(f))**: Design verification for IPL devices, including MED-210