Fresenius Kabi USA, LLC
Form 483 issued July 8, 2011 · Grand Island, New York
- Inspection
- Jun 13 – Jul 8, 2011
- Investigators
- Felix Maldonado· James D. Bridges· Kevin A. Gonzalez
- Observations
- 16
- Pages
- 18
- FEI number
- 3001833549
In short: On July 8, 2011, FDA issued a Form 483 with 16 observations to Fresenius Kabi USA, LLC in Grand Island, New York (FEI 3001833549) after an inspection that ran Jun 13 – Jul 8, 2011. The investigators were Felix Maldonado, James D. Bridges and Kevin A. Gonzalez. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Records of returned drug…
- 04
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
This inspection in context
Felix Maldonado
6 documents · 2009–2019
Cites 211.160 (general requirements) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Kabi USA, LLC?
FDA listed 16 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA, LLC?
Felix Maldonado, James D. Bridges and Kevin A. Gonzalez are named on this Form 483, for the inspection of Jun 13 – Jul 8, 2011. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA, LLC inspected by FDA?
The inspection ran Jun 13 – Jul 8, 2011, and the Form 483 is dated July 8, 2011.
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.