Fresenius USA Manufacturing, Inc.

FDA establishment 1713747, Ogden, Utah, United States. Part of Fresenius Medical Care AG & Co. KGaA's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.

Inspections: 12
Official action indicated: 2
Last inspection ended: Jul 24, 2026
Warning letters: 1
Recalls since 2016: 1

Inspections by Fiscal Year

FY2018 to FY2027 to date; 1 classified OAI

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

02019

12021

02023

02025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

12 inspections, newest first


Jul 24, 2026	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices	None posted	No Action Indicated (NAI)
Mar 6, 2026	Drugs · Drug Quality Assurance	2 cited references 21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. 21 CFR 211.192. Written record of investigation incomplete Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.	Official Action Indicated (OAI)
May 21, 2021	Drugs · Drug Quality Assurance	1 cited reference 21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.	Voluntary Action Indicated (VAI)
Aug 13, 2020	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
Aug 18, 2017	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
May 18, 2017	Devices · Compliance: Devices	None posted	No Action Indicated (NAI)
Jan 10, 2014	Drugs · Drug Quality AssuranceDevices · Compliance: Devices; Devices · Postmarket Assurance: Devices	None posted	Voluntary Action Indicated (VAI)
Dec 7, 2012	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices	4 cited references 21 CFR 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established. 21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established. 21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is incomplete. 21 CFR 820.30(f). Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.	Official Action Indicated (OAI)
Mar 8, 2012	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
Feb 4, 2011	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
Sep 9, 2010	Devices · Compliance: Devices	None posted	No Action Indicated (NAI)
Jun 12, 2009	Drugs · Drug Quality AssuranceDevices · Compliance: Devices	None posted	No Action Indicated (NAI)

Warning Letters

Letters naming this establishment; each opens the letter

Sterility assurance, Process validation, Out-of-specificationAug 25, 2026

Recalls

1 drug, device and biologic recalls since 2016, newest first; 0 Class I

Recalled product	Class	Classified
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter…Drug · D-0389-2021	Class II	Apr 14, 2021

Identifiers

FEI number: 1713747
FDA firm profile: Data Dashboard
Inspection program: 7382.850, Inspection of Medical Device Manufacturers
Company: Fresenius Medical Care AG & Co. KGaA

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports