fda_483 · inspection_citation · high
Pine Pharmaceuticals LLC -- FDA 483: 2 observations (2025-11-14)
- Event date
- 2025-11-14 00:00:00Z
- Observed
- 2026-07-12 22:31:32Z
- Source ID
- 3010943533-2025-11-14-190690
- Payload hash
- be6fbd8a1f41c84ee6903dd9…
Summary
Observation 2: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. Specificall y, 1 ) On 11 /4/2025, during the aseptic repackaging...
Entities
Informational only. Not legal, financial, or medical advice.