Physitemp Instruments, LLC – FDA Warning Letter, Jun 18, 2025

In a Warning Letter dated November 12, 2025, the FDA notified Physitemp Instruments, LLC of significant regulatory violations following an inspection of its Clifton, New Jersey, facility conducted between April 29 and June 18, 2025. The inspection focused on the company’s clinical electronic thermometers and temperature monitoring probes intended for human use in surgical and clinical settings. The FDA found that Physitemp violated the Federal Food, Drug, and Cosmetic Act and the Quality System regulation (21 CFR Part 820). Key issues included a failure to validate critical manufacturing processes such as sterilization and laser welding, ensuring products consistently meet safety and performance standards. The company also failed to establish adequate procedures for finished device testing, neglected to properly document and investigate nonconforming products, and lacked a robust system for evaluating customer complaints and medical device reporting. Furthermore, the FDA determined that several products were being marketed without required premarket clearance (510(k)) and lacked mandatory Unique Device Identifiers (UDI) on their labeling. Physitemp is required to respond within 15 business days with a comprehensive plan for corrective actions, including a retrospective review of past complaints and evidence of staff training. Failure to address these systemic failures may lead to regulatory actions such as product seizures, injunctions, or civil penalties.