Fresenius Kabi USA LLC
Form 483 issued September 1, 2015 · Melrose Park, Illinois
- Inspection
- Aug 17 – Sep 1, 2015
- Investigator
- Christopher D. Leach
- Observations
- 1
- Pages
- 1
- FEI number
- 1450022
In short: On September 1, 2015, 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 17 – Sep 1, 2015. The investigator was Christopher D. Leach. Most observations concern packaging & labeling; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
1 of 1 observations on this 483 concern packaging & labeling.
Most cited: 21 CFR 211.122(g)(3) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The packaging and labeling operation involving cut labels and relying on visual inspection does not provide…
This inspection in context
Christopher D. Leach
11 documents · 2013–2018
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Illinois.
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 211.122(g)(3)
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 packaging & labeling. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA LLC?
Christopher D. Leach is named on this Form 483, for the inspection of Aug 17 – Sep 1, 2015. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA LLC inspected by FDA?
The inspection ran Aug 17 – Sep 1, 2015, and the Form 483 is dated September 1, 2015.
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.