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

FDA WARNING_LETTER for Physitemp Instruments, LLC on June 18, 2025. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Physitemp Instruments, LLC on June 18, 2025. Product: devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 801

21 CFR 803.17(a)(1)

21 U.S.C. 360j(g)

FD&C Act 520(g)

21 U.S.C. 352(c)

FD&C Act 502(o)

FD&C Act 510(k)

21 U.S.C. 352(t)(2)

FD&C Act 501(h)

21 CFR 820.90(b)(2)

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Record Information

Company

Physitemp Instruments, LLC

Inspection Date

June 18, 2025

Product Type

devices

Office

Center for Devices and Radiological Health

People

ID: c522775b-7fa4-4f0f-8c83-46724ca2fda1

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