Fresenius Kabi USA, LLC
Form 483 issued March 6, 2015 · Grand Island, New York
- Inspection
- Mar 2 – Mar 6, 2015
- Investigator
- James D. Bridges
- Observations
- 2
- Pages
- 1
- FEI number
- 3001833549
In short: On March 6, 2015, FDA issued a Form 483 with 2 observations to Fresenius Kabi USA, LLC in Grand Island, New York (FEI 3001833549) after an inspection that ran Mar 2 – Mar 6, 2015. The investigator was James D. Bridges. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.103 (calculation of yield).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.103 (1×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
- 02
Aseptic processing areas are deficient regarding the system…
This inspection in context
James D. Bridges
3 documents · 2011–2015
Cites 211.113 (control of microbiological contamination) 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 211.103
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Kabi USA, LLC?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.103 (calculation of yield). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA, LLC?
James D. Bridges is named on this Form 483, for the inspection of Mar 2 – Mar 6, 2015. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA, LLC inspected by FDA?
The inspection ran Mar 2 – Mar 6, 2015, and the Form 483 is dated March 6, 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.