FDA-Inspected Site

Fresh Pak, Inc.

16 FDA inspections are on record for Fresh Pak, Inc. in Detroit, United States.

483· Form 483 issued

Detroit, United States · Last updated July 9, 2026

Overview

  • 16 FDA inspections are on record.
  • 10 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-24.

At a glance

Inspections

16

Form 483s

10

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Mar 2026 – 24 Mar 2026Foods & Cosmetics483On file
26 Jul 2023 – 4 Aug 2023Foods & Cosmetics483View 483 →
15 Jun 2023Foods & Cosmetics483On file
26 May 2021 – 28 May 2021Foods & Cosmetics483On file
24 Jun 2019 – 27 Jun 2019Foods & Cosmetics483View 483 →
4 Jan 2018 – 16 Jan 2018Foods & Cosmetics483View 483 →
20 Jul 2017Foods & Cosmetics483On file
15 Jul 2015Foods & CosmeticsClean
7 Mar 2013 – 14 Mar 2013Foods & Cosmetics483View 483 →
11 Mar 2013Foods & CosmeticsClean
17 Oct 2011Not recordedClean
13 Sep 2011Not recordedClean

Observations on record

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

4 Aug 2023
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Martin R Vowell, Hassan M Fakhreddine

4 Aug 2023
21 CFR 117.80(c)

Manufacturing, processing, packing, holding - Controls

Cited by Martin R Vowell, Hassan M Fakhreddine

27 Jun 2019
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Lauren E Sexton, Theodore N Sietsema, Minerva Rivera, Kelly A Sparks

27 Jun 2019
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Lauren E Sexton, Theodore N Sietsema, Minerva Rivera, Kelly A Sparks

27 Jun 2019
21 CFR 117.135(c)(1)

Process Controls Procedures - Adequate

Cited by Lauren E Sexton, Theodore N Sietsema, Minerva Rivera, Kelly A Sparks

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 117.145(a)Cited across public-safe Form 483 observations4x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.405(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 110.80(b)(6)Cited across public-safe Form 483 observations2x
21 CFR 117.135(c)(1)Cited across public-safe Form 483 observations2x
21 CFR 110.40(b)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.35(d)Cited across public-safe Form 483 observations1x
21 CFR 117.40(f)Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Fresh Pak, Inc.'s 10 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