fda_483 · inspection_citation · high
Park Avenue Compounding -- FDA 483: 7 observations (2025-09-23)
- Event date
- 2025-09-23 00:00:00Z
- Observed
- 2026-07-12 22:31:37Z
- Source ID
- 1972829-2025-09-23-190024
- Payload hash
- efd16af61bb86d7168f2d3e7…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. Specifically, A. Media...
Entities
Informational only. Not legal, financial, or medical advice.