Fresenius Kabi USA LLC
Form 483 issued June 30, 2022 · Melrose Park, Illinois
- Inspection
- May 18 – Jun 30, 2022
- Observations
- 6
- Pages
- 15
- FEI number
- 1450022
In short: On June 30, 2022, FDA issued a Form 483 with 6 observations to Fresenius Kabi USA LLC in Melrose Park, Illinois (FEI 1450022) after an inspection that ran May 18 – Jun 30, 2022. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 6 observations.
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 of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Laboratory records are deficient in that they do not include a complete record of all…
- 04
Employees are not given training in the particular operations they perform as part of their function…
This inspection in context
Questions about this 483
What did FDA find at Fresenius Kabi USA LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
When was Fresenius Kabi USA LLC inspected by FDA?
The inspection ran May 18 – Jun 30, 2022, and the Form 483 is dated June 30, 2022.
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.