Fresenius Kabi USA, LLC
Form 483 issued August 30, 2023 · Grand Island, New York
- Inspection
- Aug 28 – Aug 30, 2023
- Investigator
- Matthew D. Schnittker
- Observations
- 1
- Pages
- 2
- FEI number
- 3001833549
In short: On August 30, 2023, FDA issued a Form 483 with 1 observation to Fresenius Kabi USA, LLC in Grand Island, New York (FEI 3001833549) after an inspection that ran Aug 28 – Aug 30, 2023. The investigator was Matthew D. Schnittker. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
This inspection in context
Matthew D. Schnittker
12 documents · 2015–2025
Cites 820.30(a) (design controls) 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 820.100(a)
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 cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA, LLC?
Matthew D. Schnittker is named on this Form 483, for the inspection of Aug 28 – Aug 30, 2023. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA, LLC inspected by FDA?
The inspection ran Aug 28 – Aug 30, 2023, and the Form 483 is dated August 30, 2023.
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.