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

Source: https://www.keypedia.com/records/483/physitemp-instruments-llc/1877d888-bc44-42e2-8217-e19a47ee07db

> FDA 483 for Physitemp Instruments, LLC on June 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Physitemp Instruments, LLC
- Inspection Date: 2025-06-18
- Product Type: device
- Office Name: New Jersey District Office
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2025-06-18](https://www.keypedia.com/records/warning_letter/physitemp-instruments-llc/c522775b-7fa4-4f0f-8c83-46724ca2fda1)

## Related Officers

- [Jaro P. Perera](https://www.keypedia.com/people/jaro-p-perera/5555676c-2151-4ecd-bad8-72a1ddab8936)

Company: https://www.keypedia.com/companies/physitemp-instruments-llc/2d4a2cec-76ff-43e4-89ba-9fcb62a23ed5

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248