FDA EIR - Bio-Thesiometer USA - January 19, 2018

An FDA inspection of Bio-Thesiometer USA LLC, a manufacturer of Class I, GMP exempt sensory threshold medical devices, was conducted from January 11-19, 2018. This initial inspection focused on compliance with specific regulations for complaint handling (21 CFR 820.198), general recordkeeping (21 CFR 820.180), and medical device reporting (21 CFR 803). The inspection revealed two significant observations: the absence of established procedures for receiving, reviewing, and evaluating customer complaints, and the lack of written procedures for evaluating and submitting Medical Device Reports (MDRs). Existing complaint documentation was found insufficient, lacking details such as MDR assessments, investigation needs, complainant information, and documented corrective actions. While past complaints for a twisted power cord led to an undocumented design change that resolved the issue, the firm lacked a formal process for handling and documenting such events, or for assessing MDR reportability. Management acknowledged these deficiencies and committed to correcting both observations within two weeks by establishing comprehensive complaint handling and MDR procedures, and by enhancing their complaint documentation to meet regulatory requirements, thereby ensuring proper assessment and reporting of device-related issues.