FDA-Inspected Site

Penner Patient Care, Inc.

6 FDA inspections are on record for Penner Patient Care, Inc. in Aurora, United States.

483· Form 483 issued

Aurora, United States · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-02-11.

At a glance

Inspections

6

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Feb 2025 – 11 Feb 2025Medical Devices & Rad Health483View 483 →
20 Jun 2016 – 21 Jun 2016Medical Devices & Rad Health483View 483 →
8 Jul 2014 – 10 Jul 2014Medical Devices & Rad Health483View 483 →
1 Apr 2010Not recordedClean
28 Jul 2005Not recordedClean
14 May 2004Not recordedClean

Observations on record

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

11 Feb 2025
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Eric C Fox

11 Feb 2025
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Eric C Fox

11 Feb 2025
21 CFR 803.17(a)(3)

Lack of System for Timely Submission of Reports

Cited by Eric C Fox

11 Feb 2025
21 CFR 803.17(a)(3)

Lack of System for Timely Submission of Reports

Cited by Eric C Fox

11 Feb 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Eric C Fox

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 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 801.20(a)Cited across public-safe Form 483 observations2x
21 CFR 803.17(a)(3)Cited across public-safe Form 483 observations2x
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 820.50(a)Cited across public-safe Form 483 observations2x
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Penner Patient Care, Inc.'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