fda_483 · inspection_citation · high
QuVa Pharma, Inc. -- FDA 483: 4 observations (2025-03-04)
- Event date
- 2025-03-04 00:00:00Z
- Observed
- 2026-07-12 22:32:29Z
- Source ID
- 3013931875-2025-03-04-186263
- Payload hash
- 5a6535dd3a68ba5b09b47b17…
Summary
Observation 1: The accmacy, specificity and reproducibility of test methods have not been established. Specifically, Yom finn did not appropriately quali fy the per fo nnance qualification, RDIReport-...
Entities
Informational only. Not legal, financial, or medical advice.