Fresenius Kabi USA, LLC
Form 483 issued May 14, 2026 · Grand Island, New York
- Inspection
- May 5 – May 14, 2026
- Investigators
- Joshrenzo N. Ramilo· Mindy M. Chou
- Observations
- 2
- Pages
- 4
- FEI number
- 3001833549
In short: On May 14, 2026, FDA issued a Form 483 with 2 observations to Fresenius Kabi USA, LLC in Grand Island, New York (FEI 3001833549) after an inspection that ran May 5 – May 14, 2026. The investigators were Joshrenzo N. Ramilo and Mindy M. Chou. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (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
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Joshrenzo N. Ramilo
1 document · 2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmFresenius Kabi USA, LLC history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Kabi USA, LLC?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA, LLC?
Joshrenzo N. Ramilo and Mindy M. Chou are named on this Form 483, for the inspection of May 5 – May 14, 2026. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA, LLC inspected by FDA?
The inspection ran May 5 – May 14, 2026, and the Form 483 is dated May 14, 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.