fda_483 · inspection_citation · high

BPI Labs, LLC -- FDA 483: 1 observation (2026-04-17)

Event date
2026-04-17 00:00:00Z
Observed
2026-07-12 22:28:53Z
Source ID
3015156709-2026-04-17-192439
Payload hash
95624332103893c681ef7e63

Summary

Observation 3: The written stability program for diug products does not include reliable, meaningful and specific test methods. Sp ecifically, Your fnm failed to establish and follow an adequate writt...

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