Drug factory · FDA FEI 1713747
Fresenius Medical Care North America
475 West 13th Street, Ogden, UT, United States
Serious problems, FDA action at FDA's last inspection, Mar 6, 2026.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
8 drug inspections on record since 2009: 1 with no problems, 6 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Calcium Cation and Potassium Cation and Sodium Cation | Makes it, tests it, packages it, labels it and sterilizes it | Becton Dickinson and Company, Fresenius Kabi USA, LLC | 17271-710, 65219-479 |
| Sodium Cation | Makes it, tests it, packages it, labels it and sterilizes it | Becton Dickinson and Company, Fresenius Kabi USA, LLC | 17271-701, 65219-282, 65219-328 +6 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 6, 2026 | Serious problems, FDA action | Drug Quality Assurance | 2 |
| May 21, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 13, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 18, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 10, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 8, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 4, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 12, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 6, 2026 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
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. - Written record of investigation incomplete 21 CFR 211.192
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.
May 21, 2021 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.