Fresenius Medical Care North America
FDA inspection history in Ogden, Utah, 2020 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2020: one Form 483; 2021: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–21Two Form 483s, at Ogden, Utah.
- 2020The longest 483 on file: 2 observations over 3 pages at Ogden, Utah.
- 2026One warning letter, at Ogden, Utah.
Cited most
Across all Fresenius Medical Care North America observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
The complete Fresenius Medical Care North America file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Ogden, Utah
Two Form 483s and one warning letter · 2020 to 2026 · 3 observations
Latest: Warning letter, Aug 25, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-08-25 | Warning letter Warning letter | Ogden, Utah | — | $99 |
| 2021-05-21 | 483 Form 483 | Ogden, Utah | 1 | $99 |
| 2020-08-13 | 483 Form 483 | Ogden, Utah | 2 | $99 |
Investigators on these documents
FEI number 1713747 · most recent document Aug 25, 2026
About Fresenius Medical Care North America
How many FDA Form 483s has Fresenius Medical Care North America received?
FDA Intel has 2 Form 483s on file for Fresenius Medical Care North America; the most recent is dated May 21, 2021.
When was Fresenius Medical Care North America last inspected by FDA?
The most recent FDA inspection document on file for Fresenius Medical Care North America is a Form 483 dated May 21, 2021, for the site in Ogden, Utah.
What did FDA cite at Fresenius Medical Care North America?
The regulations cited most in the observations on file for Fresenius Medical Care North America are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.
Has Fresenius Medical Care North America received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Fresenius Medical Care North America; the most recent is dated Aug 25, 2026.