483
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA 483, Mar 18, 2022
Record Details
An FDA inspection of Ivenix, Inc. in North Andover, MA, identified a significant issue related to design verification. The firm failed to confirm that design output meets design input requirements, specifically regarding the pressure resistance of administration set drip chambers. This indicates a moderate severity finding concerning product design and testing.
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