fda_483 · inspection_citation · high
AnazaoHealth Corporation -- FDA 483: 3 observations (2025-08-08)
- Event date
- 2025-08-08 00:00:00Z
- Observed
- 2026-07-12 22:32:00Z
- Source ID
- 3011152407-2025-08-08-188525
- Payload hash
- 4450d38ab88f68d6c0b7f6f3…
Summary
Observation 2: Procedures designed to prevent microbiological contamination of diug products pmp o1ting to be sterile are not establish ed, written and fo llowed. Specifically, A. During aseptic opera...
Entities
Informational only. Not legal, financial, or medical advice.