fda_483 · inspection_citation · high

Farmakeio Outsourcing LLC -- FDA 483: 5 observations (2025-09-05)

Event date
2025-09-05 00:00:00Z
Observed
2026-07-12 22:31:41Z
Source ID
3014982757-2025-09-05-189926
Payload hash
6132f80be088eea3628940b5

Summary

Observation 1: There is a failme to thoroughly review any unexplained discrepancy and the failme of a batch or any of its components to meet any of its specifications whether or not the batch has been...

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