Fresenius Kabi USA, LLC
Form 483 issued February 13, 2026 · Wilson, North Carolina
- Inspection
- Feb 3 – Feb 13, 2026
- Investigators
- Ankur C. Patel· Karishma G. Gopaul· Yvins Dezan
- Observations
- 6
- Pages
- 8
- FEI number
- 3008887707
In short: On February 13, 2026, FDA issued a Form 483 with 6 observations to Fresenius Kabi USA, LLC in Wilson, North Carolina (FEI 3008887707) after an inspection that ran Feb 3 – Feb 13, 2026. The investigators were Ankur C. Patel, Karishma G. Gopaul and Yvins Dezan. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Repeat) Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
(Repeat) Equipment and utensils are not cleaned, maintained at appropriate intervals to prevent malfunctions contamination that…
- 03
(Repeat) There is a failure to thoroughly review any unexplained discrepancy and the failure of a…
- 04
The responsibilities and procedures applicable to the quality unit are not in…
This inspection in context
Ankur C. Patel
9 documents · 2021–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmFresenius Kabi USA, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Kabi USA, LLC?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA, LLC?
Ankur C. Patel, Karishma G. Gopaul and Yvins Dezan are named on this Form 483, for the inspection of Feb 3 – Feb 13, 2026. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA, LLC inspected by FDA?
The inspection ran Feb 3 – Feb 13, 2026, and the Form 483 is dated February 13, 2026.
How do I get the full Form 483 for Fresenius Kabi USA, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.