fda_483 · inspection_citation · high

Mixlab WI LLC -- FDA 483: 7 observations (2025-07-24)

Event date: 2025-07-24 00:00:00Z
Observed: 2026-07-12 22:32:00Z
Source ID: 3005946041-2025-07-24-193420
Payload hash: 0a6101e9ed06734bc22827b3…

Summary

Observation 1: The responsibilities and procedures applicable to the quality control unit are not fully followed. Specifically, A. The written procedure, SOP MLWl-001-04, titled' on-Sterile Compoundin...

Entities

Mixlab WI LLC

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