fda_483 · inspection_citation · high

Fagron Compounding Services -- FDA 483: 3 observations (2025-08-08)

Event date
2025-08-08 00:00:00Z
Observed
2026-07-12 22:31:58Z
Source ID
3012104093-2025-08-08-188683
Payload hash
2857c0ee7ceef5be4a53c821

Summary

Observation 2: There is a failure to thorough ly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has b...

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