fda_483 · inspection_citation · high
Immacule Lifesciences Private Limited -- FDA 483: 6 observations (2025-09-18)
- Event date
- 2025-09-18 00:00:00Z
- Observed
- 2026-07-12 22:31:37Z
- Source ID
- 3014210753-2025-09-18-189747
- Payload hash
- be660ed082bd3aa54ab5765d…
Summary
Observation 2: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. 4 A. On September 10, 2025, we observed when the...
Informational only. Not legal, financial, or medical advice.