fda_483 · inspection_citation · high

Aurolife Pharma LLC -- FDA 483: 10 observations (2025-04-10)

Event date
2025-04-10 00:00:00Z
Observed
2026-07-12 22:32:25Z
Source ID
3014028588-2025-04-10-186635
Payload hash
55ef05565f43fda81a73255e

Summary

Observation 2: There is a failure to thoroughly review any unexplained discrepancy whether or no t the batch has been already distributed. Specifically, t he following deviations were reviewed and fou...

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