Fresenius Kabi USA, LLC
Form 483 issued March 30, 2017 · Grand Island, New York
- Observations
- 1
- Pages
- 3
- FEI number
- 3001833549
In short: On March 30, 2017, FDA issued a Form 483 with 1 observation to Fresenius Kabi USA, LLC in Grand Island, New York (FEI 3001833549). Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Regarding procedures designed to prevent microbiological contamination of drug products purporting to be sterile: a. A…
This inspection in context
Questions about this 483
What did FDA find at Fresenius Kabi USA, LLC?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Fresenius Kabi USA, LLC inspected by FDA?
This Form 483 is dated March 30, 2017.
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.