fda_483 · inspection_citation · high

BSO, LLC -- FDA 483: 8 observations (2025-06-27)

Event date: 2025-06-27 00:00:00Z
Observed: 2026-07-12 22:32:05Z
Source ID: 3030548360-2025-06-27-188193
Payload hash: 878a5757dd7ace9d57fbd2e2…

Summary

Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process. Specifically, Yo...

Entities

BSO, LLC

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