fda_483 · inspection_citation · high
Aurobindo Pharma Ltd. Unit-XII -- FDA 483: 8 observations (2025-09-05)
- Event date
- 2025-09-05 00:00:00Z
- Observed
- 2026-07-12 22:31:42Z
- Source ID
- 3004446312-2025-09-05-189107
- Payload hash
- 589e202dbc28f0c5e9e89d3b…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed, or did not include adequate validation of the as...
Entities
Informational only. Not legal, financial, or medical advice.