FDA-Inspected Site

Physitemp Instruments, LLC

5 FDA inspections are on record for Physitemp Instruments, LLC in Clifton, United States.

483· Form 483 issued

Clifton, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-06-18.

At a glance

Inspections

5

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
29 Apr 2025 – 18 Jun 2025Medical Devices & Rad HealthWLView 483 →
25 May 2022Medical Devices & Rad HealthClean
1 May 2017 – 4 May 2017Medical Devices & Rad HealthClean
27 Dec 2011Not recorded483View 483 →
2 Sep 2008Not recorded483On file

Observations on record

Form 483 observations cited at this site, most recent first.

18 Jun 2025
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Jaro P Perera

18 Jun 2025
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Jaro P Perera

18 Jun 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jaro P Perera

18 Jun 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Jaro P Perera

18 Jun 2025
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Jaro P Perera

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 801.20(a)Cited across public-safe Form 483 observations1x
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.180(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(b)Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x
21 CFR 830.300(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Physitemp Instruments, LLC's 3 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat