Fresenius Kabi USA LLC
Form 483 issued December 11, 2013 · Melrose Park, Illinois
- Inspection
- Sep 25 – Dec 11, 2013
- Investigator
- Russell K. Riley
- Observations
- 3
- Pages
- 2
- FEI number
- 1450022
In short: On December 11, 2013, FDA issued a Form 483 with 3 observations to Fresenius Kabi USA LLC in Melrose Park, Illinois (FEI 1450022) after an inspection that ran Sep 25 – Dec 11, 2013. The investigator was Russell K. Riley. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Russell K. Riley
7 documents · 2013–2015
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 211.22(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 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA LLC?
Russell K. Riley is named on this Form 483, for the inspection of Sep 25 – Dec 11, 2013. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA LLC inspected by FDA?
The inspection ran Sep 25 – Dec 11, 2013, and the Form 483 is dated December 11, 2013.
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.