fda_483 · inspection_citation · high
Empower Clinic Services LLC dba Empower Pharma -- FDA 483: 8 observations (2025-12-14)
- Event date
- 2025-12-14 00:00:00Z
- Observed
- 2026-07-12 22:31:14Z
- Source ID
- 3011887629-2025-12-14-190736
- Payload hash
- 4e736164a4fdb3fcbe5a4ddc…
Summary
Observation 1: Procedmes designed to prevent microbiologi cal contaminati on of diug products pmpo1iing to be sterile are not established, written and followed. Specifically, A. Aseptic process simula...
Informational only. Not legal, financial, or medical advice.