fda_483 · inspection_citation · high

IntegraDose Compounding Services LLC -- FDA 483: 3 observations (2025-07-25)

Event date
2025-07-25 00:00:00Z
Observed
2026-07-12 22:32:00Z
Source ID
3014483112-2025-07-25-188467
Payload hash
26aadba2157f80f22a0d0db5

Summary

Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed. ***Repeat Observation from F DA Inspections ending 0...

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