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All Warning Letters

Physitemp Instruments, LLC

Warning LetterOpen

Recipient Title Vice President of Sales and Marketing, Physitemp Instruments, LLC, 189 Sargeant Avenue Clifton , NJ 07013 United States, (b)(4)Issued Nov 12, 2025Center for Devices and Radiological Health

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations17

Issue DateNov 12, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Physitemp Instruments, LLC
Location: Recipient Title Vice President of Sales and Marketing, Physitemp Instruments, LLC, 189 Sargeant Avenue Clifton , NJ 07013 United States, (b)(4)
FEI Number: N/A
Country: United States
Issue Date: November 12, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Subject

CGMP/QSR/Medical Devices/Adulterated

Physitemp Instruments, LLC FDA Warning Letter, November 12, 2025