fda_483 · inspection_citation · high
TAILSTORM HEALTH INC -- FDA 483: 3 observations (2025-11-14)
- Event date
- 2025-11-14 00:00:00Z
- Observed
- 2026-07-12 22:31:32Z
- Source ID
- 3022483154-2025-11-14-190200
- Payload hash
- d735b5b05750d88e833c6125…
Summary
Observation 1: Established laborato1y control mechanisms are not fo llowed. Speci fi cally, Your fnm does not have an establish ed system suitability procedure. Your fnm per fo1ms the Light Obscuratio...
Entities
Informational only. Not legal, financial, or medical advice.