fda_483 · inspection_citation · high
Alvotech Hf -- FDA 483: 10 observations (2025-07-04)
- Event date
- 2025-07-04 00:00:00Z
- Observed
- 2026-07-12 22:32:05Z
- Source ID
- 3013702557-2025-07-04-189485
- Payload hash
- 7f299ac68d9f8a4f1986a452…
Summary
Observation 1: Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they...
Entities
Informational only. Not legal, financial, or medical advice.