fda_483 · inspection_citation · high

SKNV -- FDA 483: 1 observation (2025-03-06)

Event date
2025-03-06 00:00:00Z
Observed
2026-07-12 22:32:29Z
Source ID
3012384835-2025-03-06-186005
Payload hash
3aa363869159595d2e5cf114

Summary

Observation 1: There is a failure to thoroughly review any unexplained discrepancy whether or not the batch h as been aheady distributed. A. On 09 /18/24 in anticipation of your production batch of Ma...

Entities

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