fda_483 · inspection_citation · high
Orchid Pharma Limited -- FDA 483: 6 observations (2025-02-18)
- Event date
- 2025-02-18 00:00:00Z
- Observed
- 2026-07-12 22:32:46Z
- Source ID
- 3003747558-2025-02-18-191891
- Payload hash
- 2fd78e73ad02677c5de70c09…
Summary
Observation 2: You have not establish ed the written procedure to ensure that your process can per fo1m e ffectively and reproducibly to manufact ure an inte1mediate or API meeting its predete1mined s...
Entities
Informational only. Not legal, financial, or medical advice.