fda_483 · inspection_citation · high

Qualgen LLC -- FDA 483: 5 observations (2025-09-04)

Event date: 2025-09-04 00:00:00Z
Observed: 2026-07-12 22:31:44Z
Source ID: 3011286349-2025-09-04-190601
Payload hash: e6b7805b16858e3ad526529d…

Summary

Observation 1: There is ins ufficient physical or spatial separation from operations and other mug products to prevent mix-ups and cross-contamination. Specifically, Hazardous mugs were produced witho...

Entities

Qualgen LLC

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