fda_483 · inspection_citation · high
Suzhou Suncadia Biopharmaceuticals Co., Ltd. -- FDA 483: 3 observations (2025-01-06)
- Event date
- 2025-01-06 00:00:00Z
- Observed
- 2026-07-12 22:32:49Z
- Source ID
- 3015786877-2025-01-06-186633
- Payload hash
- 2bbe625bc8528b6d1bd395e7…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not fully established or followed. Specifically, A Your media fill program is ...
Informational only. Not legal, financial, or medical advice.