fda_483 · inspection_citation · high

Advanced Nutriceuticals, LLC -- FDA 483: 5 observations (2024-11-22)

Event date
2024-11-22 00:00:00Z
Observed
2026-07-12 22:32:51Z
Source ID
3010039017-2024-11-22-185235
Payload hash
8e45a3ae1e4883049af08e2f

Summary

Observation 1: Failure to conduct media fills that closely simulate aseptic production operations un de r the worst-case, most-challenging, and stressful conditions. Specifically, The media fill proce...

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