fda_483 · inspection_citation · high

Denver Solutions, LLC -- FDA 483: 7 observations (2025-12-11)

Event date
2025-12-11 00:00:00Z
Observed
2026-07-12 22:31:14Z
Source ID
3013438582-2025-12-11-190719
Payload hash
be017af087f27ca920e99505

Summary

Observation 1: Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality ...

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