fda_483 · inspection_citation · high
VA San Diego Healthcare Systems -- FDA 483: 11 observations (2026-05-08)
- Event date
- 2026-05-08 00:00:00Z
- Observed
- 2026-07-12 22:28:53Z
- Source ID
- 2071629-2026-05-08-193454
- Payload hash
- d8051d943f5371a644d340bc…
Summary
Observation 1: Smoke studies were inadequately performed under dynamic conditions. Specifically, Your firm did not conduct smoke studies under dynamic conditions, simulating worst-case production acti...
Entities
Informational only. Not legal, financial, or medical advice.