Atlas

FDA-Inspected Site

Fresenius USA Manufacturing, Inc.

14 FDA inspections are on record for Fresenius USA Manufacturing, Inc. in Ogden, United States.

483· Form 483 issued

Ogden, United States · Last updated July 9, 2026

Overview

  • 14 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-06.

At a glance

Inspections

14

Form 483s

8

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Mar 2026 – 6 Mar 2026Human Drugs483View 483 →
19 May 2021 – 21 May 2021Human Drugs483View 483 →
5 Aug 2020 – 13 Aug 2020Human Drugs483View 483 →
14 Aug 2017 – 18 Aug 2017Human Drugs483View 483 →
15 May 2017 – 18 May 2017Medical Devices & Rad HealthClean
6 Jan 2014 – 10 Jan 2014Medical Devices & Rad Health483View 483 →
7 Dec 2012Not recordedWLView 483 →
8 Mar 2012Not recorded483View 483 →
4 Feb 2011Not recorded483On file
9 Sep 2010Not recordedClean
12 Jun 2009Not recordedClean
13 Jun 2007Not recordedClean

Observations on record

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

6 Mar 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Nicholas L Hunt

6 Mar 2026
21 CFR 211.192

Written record of investigation incomplete

Cited by Nicholas L Hunt

21 May 2021
21 CFR 211.192

Written record of investigation incomplete

Cited by Saied A Asbagh

13 Aug 2020
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Nayan J Patel

13 Aug 2020
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Nayan J Patel

Investigators

FDA investigators tied to this site in the record.

Nayan J Patel2 insp.
Ginger M Sykes2 insp.
Nicholas L Hunt1 insp.
Saied A Asbagh1 insp.
Jamie L Dion1 insp.
Gerard T Schneider1 insp.
Vicky L Cruz1 insp.
James R Montero1 insp.
Michael A Charles1 insp.
Zachery L Miller1 insp.
Ashleigh P Wodushek1 insp.
Janet Pulver1 insp.
Erika V Butler1 insp.
Kimberley A Hoefen1 insp.
Theressa B Smith1 insp.
Matthew R Dionne1 insp.
Jennifer L Wolfe1 insp.
Neira Acevedo-Ramos1 insp.
Melissa F Chauvin1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations6x
21 CFR 211.100(a)Cited across public-safe Form 483 observations4x
21 CFR 211.68(a)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.68(b)Cited across public-safe Form 483 observations2x
21 CFR 820.30(g)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.80(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(c)Cited across public-safe Form 483 observations1x
21 CFR 820.30(f)Cited across public-safe Form 483 observations1x
21 CFR 820.80(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Fresenius USA Manufacturing, Inc.'s 8 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