Fresenius Kabi USA, LLC
Form 483 issued October 24, 2014 · Grand Island, New York
- Inspection
- Oct 20 – Oct 24, 2014
- Investigators
- Alice S. Tsao· James D. Bridges· Sony Mathews
- Observations
- 3
- Pages
- 2
- FEI number
- 3001833549
In short: On October 24, 2014, FDA issued a Form 483 with 3 observations to Fresenius Kabi USA, LLC in Grand Island, New York (FEI 3001833549) after an inspection that ran Oct 20 – Oct 24, 2014. The investigators were Alice S. Tsao, James D. Bridges and Sony Mathews. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
The number of containers to be sampled is not…
- 03
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) 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 211.192
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, materials and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA, LLC?
Alice S. Tsao, James D. Bridges and Sony Mathews are named on this Form 483, for the inspection of Oct 20 – Oct 24, 2014. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA, LLC inspected by FDA?
The inspection ran Oct 20 – Oct 24, 2014, and the Form 483 is dated October 24, 2014.
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.