fda_483 · inspection_citation · high

Fresenius Kabi Compounding LLC -- FDA 483: 6 observations (2025-11-05)

Event date
2025-11-05 00:00:00Z
Observed
2026-07-12 22:31:32Z
Source ID
3013438665-2025-11-05-190645
Payload hash
430ce1b688851fb8c1adca94

Summary

Observation 1: There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of i ts componen ts to meet any of its specifications whether or not the batch has ...

Informational only. Not legal, financial, or medical advice.