Fresenius Kabi USA, LLC
Form 483 issued October 13, 2023 · Grand Island, New York
- Inspection
- Oct 4 – Oct 13, 2023
- Investigators
- Jazmine N. Brown· Mindy M. Chou
- Observations
- 2
- Pages
- 5
- FEI number
- 3001833549
In short: On October 13, 2023, 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 Oct 4 – Oct 13, 2023. The investigators were Jazmine N. Brown and Mindy M. Chou. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Jazmine N. Brown
14 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.113(b)
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 and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA, LLC?
Jazmine N. Brown and Mindy M. Chou are named on this Form 483, for the inspection of Oct 4 – Oct 13, 2023. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA, LLC inspected by FDA?
The inspection ran Oct 4 – Oct 13, 2023, and the Form 483 is dated October 13, 2023.
How do I get the full Form 483 for Fresenius Kabi USA, LLC?
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