FDA EIR - American Thermal Instruments Inc - March 14, 2022

An FDA inspection of American Thermal Instruments Inc., a manufacturer of Class II Liquid Crystal Strip Forehead Thermometers, was conducted from February 23, 2022, to March 14, 2022. This inspection, carried out under medical device quality system regulations, identified six significant issues documented in an FDA-483 report. Main violations included: a lack of established process validation for manufacturing; absent design input procedures, specifically regarding the unsupported extension of product shelf-life and inadequate re-qualification testing; insufficient monitoring of production processes to ensure devices conform to specifications, with critical variables not consistently documented; deficiencies in device history record procedures, leading to missing manufacturing, inspection, and labeling documentation; failure to establish adequate purchasing control procedures, resulting in insufficient records for supplier evaluations and agreements; and an incomplete customer complaint procedure that lacked requirements for evaluating complaints for Medical Device Report (MDR) reportability. Company management, led by President Timothy J. Riazzi, acknowledged these observations, promised to correct them, and committed to submitting a written response within 15 business days. This inspection underscored recurring issues, as two observations from a prior 2018 inspection remained unaddressed.