fda_483 · inspection_citation · high
Fujifilm Diosynth Biotechnologies Texas, LLC -- FDA 483: 8 observations (2025-03-11)
- Event date
- 2025-03-11 00:00:00Z
- Observed
- 2026-07-12 22:32:27Z
- Source ID
- 3011948449-2025-03-11-192222
- Payload hash
- c435253e8542eb7fbd5d2b29…
Summary
Observation 1: Your mu lti-product manufacturing areas are not adequately controlled to prevent potential cross-contaminatio n. Specifically, a. There are no physical or procedural segregation control...
Informational only. Not legal, financial, or medical advice.