FDA-Inspected Site

Saputo Dairy Foods USA, LLC

9 FDA inspections are on record for Saputo Dairy Foods USA, LLC in Frederick, United States.

Clean· No action indicated

Frederick, United States · Last updated July 10, 2026

Overview

  • 9 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-09-28.

At a glance

Inspections

9

Form 483s

4

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
28 Sep 2022Foods & CosmeticsClean
19 Jul 2018 – 24 Jul 2018Foods & CosmeticsClean
29 Aug 2016 – 8 Sep 2016Foods & CosmeticsClean
31 Aug 2015 – 22 Sep 2015Foods & Cosmetics483View 483 →
10 Feb 2014 – 20 Feb 2014Foods & Cosmetics483View 483 →
22 Feb 2011Not recorded483View 483 →
21 Nov 2008Not recorded483View 483 →
21 Mar 2008Not recordedClean
26 Sep 2006Not recordedClean

Observations on record

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

22 Sep 2015
21 CFR 108.35(c)(3)(i)

Process adherence

Cited by Edward P Potter, Jessica D Nanini

22 Sep 2015
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Edward P Potter, Jessica D Nanini

22 Sep 2015
21 CFR 113.100(b)

Review not timely

Cited by Edward P Potter, Jessica D Nanini

22 Sep 2015
21 CFR 113.40(a)(2)(i)

Range, chart graduations

Cited by Edward P Potter, Jessica D Nanini

22 Sep 2015
21 CFR 113.40(g)(1)(i)(A)

Aseptic processing: reference device, identity, tag, seal

Cited by Edward P Potter, Jessica D Nanini

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 110.40(f)Cited across public-safe Form 483 observations3x
21 CFR 113.40(g)(4)Cited across public-safe Form 483 observations3x
21 CFR 113.83Cited across public-safe Form 483 observations3x
21 CFR 113.89Cited across public-safe Form 483 observations3x
21 CFR 113.40(g)(1)(i)(A)Cited across public-safe Form 483 observations2x
21 CFR 113.40(g)(1)(i)(F)Cited across public-safe Form 483 observations2x
21 CFR 113.60(a)(3)Cited across public-safe Form 483 observations2x
21 CFR 108.35(c)(3)(i)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 113.100(b)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(2)(i)Cited across public-safe Form 483 observations1x
21 CFR 113.40(g)(1)(i)(B)(3)Cited across public-safe Form 483 observations1x
21 CFR 113.40(g)(2)(i)(A)Cited across public-safe Form 483 observations1x
21 CFR 113.40(g)(2)(ii)(B)Cited across public-safe Form 483 observations1x
21 CFR 113.60(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Saputo Dairy Foods USA, LLC's 4 Form 483s

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