FDA WARNING_LETTER - Tianjin Bolang Science-Technology Development Co., Ltd. - March 30, 2021

On June 17, 2021, the FDA issued a Warning Letter to Hi-Tech Green Industrial Base in Tianjin, China, following an inspection from March 22-30, 2021. The inspection revealed that the firm's manufactured devices, including Otoscopes, Rigid Laryngoscopes, and Rigid Nasopharyngoscopes, are adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820). Additionally, the Class II Rigid Nasopharyngoscope devices are misbranded under 21 U.S.C. § 352(t)(2) for failing to provide information required by Medical Device Reporting (MDR) regulations (21 CFR Part 803).

Significant violations include the failure to establish and maintain procedures for design control (21 CFR 820.30(a)), corrective and preventive actions (21 CFR 820.100(a)), complaint handling (21 CFR 820.198(a)), and control and distribution of finished devices (21 CFR 820.160). The firm also failed to maintain Device Master Records (21 CFR 820.181), Device History Records (21 CFR 820.184), and a Quality System Record (21 CFR 820.186). Furthermore, the firm lacked sufficient personnel with adequate training and experience (21 CFR 820.25(a)) and failed to develop written MDR procedures (21 CFR 803.17).

The firm's April 19, 2021, response to the FDA 483 observations was largely deemed inadequate due to a lack of detail, missing procedures, or insufficient evidence of implementation. Consequently, the firm's devices are subject to refusal of admission into the U.S. under section 801(a) of the Act. Hi-Tech Green Industrial Base must provide a written response within fifteen business days detailing specific corrective actions, prevention plans, and implementation timetables, including documentation, to address these systemic quality system and compliance issues.