Fresenius Kabi USA LLC
Form 483 issued February 6, 2026 · Melrose Park
- Inspection
- Jan 27 – Feb 6, 2026
- Investigators
- Claude Garay· Joohi Castelvetere· Robert J. Ham
- Observations
- 3
- Pages
- 16
- FEI number
- 1450022
In short: On February 6, 2026, FDA issued a Form 483 with 3 observations to Fresenius Kabi USA LLC in Melrose Park (FEI 1450022) after an inspection that ran Jan 27 – Feb 6, 2026. The investigators were Claude Garay, Joohi Castelvetere and Robert J. Ham. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into the failure of a batch or any of its components to…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Claude Garay
1 document · 2026
Cites 211.113 (control of microbiological contamination) more than any other section.
The firmFresenius Kabi USA LLC history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Kabi USA LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA LLC?
Claude Garay, Joohi Castelvetere and Robert J. Ham are named on this Form 483, for the inspection of Jan 27 – Feb 6, 2026. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA LLC inspected by FDA?
The inspection ran Jan 27 – Feb 6, 2026, and the Form 483 is dated February 6, 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.