Fresenius Kabi USA, LLC
Form 483 issued August 12, 2019 · Grand Island, New York
- Inspection
- Jul 25 – Aug 12, 2019
- Investigator
- Johnna L. Bleem
- Observations
- 2
- Pages
- 3
- FEI number
- 3001833549
In short: On August 12, 2019, 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 Jul 25 – Aug 12, 2019. The investigator was Johnna L. Bleem. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.110 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which of those manufacturing processes that may be responsible for causing…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Johnna L. Bleem
6 documents · 2019–2021
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 211.110
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 quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA, LLC?
Johnna L. Bleem is named on this Form 483, for the inspection of Jul 25 – Aug 12, 2019. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA, LLC inspected by FDA?
The inspection ran Jul 25 – Aug 12, 2019, and the Form 483 is dated August 12, 2019.
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.