fda_483 · inspection_citation · high
Samsung Bioepis Co. Ltd. -- FDA 483: 2 observations (2024-11-22)
- Event date
- 2024-11-22 00:00:00Z
- Observed
- 2026-07-12 22:32:51Z
- Source ID
- 3010031951-2024-11-22-186643
- Payload hash
- a420bf3591e18b2630ee6d92…
Summary
Observation 1: Procedures describ ing the handling of written and oral complaints related to dtu g products are n ot written and/or fo llowed. Specifically, A. Your complaint handling procedure, SOP-G...
Entities
Informational only. Not legal, financial, or medical advice.