fda_483 · inspection_citation · high

ProRx LLC -- FDA 483: 3 observations (2025-09-19)

Event date
2025-09-19 00:00:00Z
Observed
2026-07-12 22:31:36Z
Source ID
3022250654-2025-09-19-190142
Payload hash
4647d29e442976358fca8f4f

Summary

Observation 1: There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or n ot the batch has b...

Entities

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