Fresenius Kabi USA LLC
Form 483 issued August 24, 2023 · Melrose Park, Illinois
- Inspection
- Aug 14 – Aug 24, 2023
- Investigators
- Chad W. Rice· Nicholas J. Presto
- Observations
- 1
- Pages
- 3
- FEI number
- 1450022
In short: On August 24, 2023, FDA issued a Form 483 with 1 observation to Fresenius Kabi USA LLC in Melrose Park, Illinois (FEI 1450022) after an inspection that ran Aug 14 – Aug 24, 2023. The investigators were Chad W. Rice and Nicholas J. Presto. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Chad W. Rice
8 documents · 2023–2026
Cites 211.113(a) (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Kabi USA LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA LLC?
Chad W. Rice and Nicholas J. Presto are named on this Form 483, for the inspection of Aug 14 – Aug 24, 2023. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA LLC inspected by FDA?
The inspection ran Aug 14 – Aug 24, 2023, and the Form 483 is dated August 24, 2023.
How do I get the full Form 483 for Fresenius Kabi USA LLC?
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