FDA WARNING_LETTER - Dongguan Jianwei Electronics Products Co., Ltd. - July 02, 2015

An FDA inspection of Dongguan Jianwei Electronics Products Co. Ltd. in Dongguan City, China, from June 29 to July 2, 2015, revealed that the firm's infrared ear, digital, and rectal thermometers are adulterated. This is due to non-conformity with the Quality System regulation (21 CFR Part 820) regarding manufacturing controls. The FDA reviewed the firm's August 2, 2015, response but found it largely inadequate or its adequacy undetermined. Key violations include: 1) Failure to adequately ensure process validation (21 CFR 820.75(a)). 2) Failure to establish and maintain adequate procedures for the identification, documentation, validation, or verification of design changes prior to implementation (21 CFR 820.30(i)). 3) Failure to validate computer software for its intended use (21 CFR 820.70(i)). 4) Failure to adequately establish and maintain procedures to control all required documents (21 CFR 820.40). As a result, the firm's devices are subject to refusal of admission into the U.S. (detention without physical examination). The firm must provide a written response within fifteen business days detailing specific corrective actions, including documentation and a timetable for systemic problem resolution. Failure to comply may also impact federal contracts and premarket approval applications for Class III devices.