Fresenius Kabi USA, LLC
Form 483 issued February 5, 2019 · Wilson, North Carolina
- Observations
- 2
- Pages
- 1
- FEI number
- 3008887707
In short: On February 5, 2019, FDA issued a Form 483 with 2 observations to Fresenius Kabi USA, LLC in Wilson, North Carolina (FEI 3008887707). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (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
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Questions about this 483
What did FDA find at Fresenius Kabi USA, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). 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 February 5, 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.