FDA-Inspected Site

Padagis US LLC

20 FDA inspections are on record for Padagis US LLC in Minneapolis, United States.

483· Form 483 issued

Minneapolis, United States · Last updated July 9, 2026

Overview

  • 20 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-08.

At a glance

Inspections

20

Form 483s

7

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
30 Mar 2026 – 8 Apr 2026Foods & Cosmetics483View 483 →
3 Sep 2024 – 6 Sep 2024Human Drugs483View 483 →
29 Jan 2024 – 31 Jan 2024Human DrugsClean
1 May 2023 – 5 May 2023Human DrugsClean
8 Feb 2022 – 18 Feb 2022Human Drugs483View 483 →
15 Oct 2019 – 23 Oct 2019Human DrugsClean
16 Jul 2018 – 31 Jul 2018Human Drugs483View 483 →
7 Jun 2017 – 7 Jul 2017Human Drugs483View 483 →
5 Nov 2013 – 6 Nov 2013Human DrugsClean
6 Feb 2013Not recordedClean
19 Nov 2010Not recorded483View 483 →
11 Dec 2009Not recorded483On file

Observations on record

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

8 Apr 2026
21 CFR 111.70(e)

Specifications - finished dietary supplement

Cited by Courtney R Ingalsbe, Beatrix D Hippe, Elizabeth R Bloom

8 Apr 2026
21 CFR 114.83

Scheduled process establishment

Cited by Courtney R Ingalsbe, Beatrix D Hippe, Elizabeth R Bloom

8 Apr 2026
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Courtney R Ingalsbe, Beatrix D Hippe, Elizabeth R Bloom

8 Apr 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Courtney R Ingalsbe, Beatrix D Hippe, Elizabeth R Bloom

8 Apr 2026
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Courtney R Ingalsbe, Beatrix D Hippe, Elizabeth R Bloom

Investigators

FDA investigators tied to this site in the record.

Elizabeth R Bloom1 insp.
Denise M Digiulio1 insp.
Courtney R Tiegs1 insp.
Gregory W Smith1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations4x
21 CFR 211.110(a)Cited across public-safe Form 483 observations3x
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(5)Cited across public-safe Form 483 observations2x
21 CFR 211.68(a)Cited across public-safe Form 483 observations2x
21 CFR 211.80(a)Cited across public-safe Form 483 observations2x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x
21 CFR 114.83Cited across public-safe Form 483 observations1x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(6)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Padagis US LLC's 7 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