FDA 483 - Physitemp Instruments, LLC - June 18, 2025

An FDA inspection of Physitemp Instruments, LLC revealed significant quality system deficiencies in the manufacturing of temperature probes and clinical thermometers. The firm lacked adequate procedures for finished device acceptance, process validation, nonconforming product control, and complaint handling. Additionally, the inspection found issues with supplier control, corrective and preventive actions, medical device reporting, and Unique Device Identifier (UDI) labeling and database submissions.