Fresenius Kabi USA, LLC
FDA inspection history in Wilson, North Carolina, 2019 to 2026
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2023: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Wilson, North Carolina.
- 2023One Form 483, at Wilson, North Carolina.
- 2026One Form 483, at Wilson, North Carolina.
- 2026The longest 483 on file: 6 observations over 8 pages at Wilson, North Carolina.
Cited most
Across all Fresenius Kabi USA observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.160General requirements1
The complete Fresenius Kabi USA 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
Wilson, North Carolina
Three Form 483s · 2019 to 2026 · 14 observations
Latest: Form 483, Feb 13, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-13 | 483 Form 483 | Wilson, North Carolina | 6 | $99 |
| 2023-06-13 | 483 Form 483 | Wilson, North Carolina | 6 | $99 |
| 2019-02-05 | 483 Form 483 | Wilson, North Carolina | 2 | $99 |
Investigators on these documents
Ankur C. Patel (1)Brittny C. Cargo (1)Karishma G. Gopaul (1)Yvins Dezan (1)
FEI number 3008887707 · most recent document Feb 13, 2026
About Fresenius Kabi USA, LLC
How many FDA Form 483s has Fresenius Kabi USA, LLC received?
FDA Intel has 3 Form 483s on file for Fresenius Kabi USA, LLC; the most recent is dated Feb 13, 2026.
When was Fresenius Kabi USA, LLC last inspected by FDA?
The most recent FDA inspection document on file for Fresenius Kabi USA, LLC is a Form 483 dated Feb 13, 2026, for the site in Wilson, North Carolina.
What did FDA cite at Fresenius Kabi USA, LLC?
The regulations cited most in the observations on file for Fresenius Kabi USA, LLC are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.192 (Production record review), 2 times.