fda_483 · inspection_citation · high
Wells Pharma of Houston LLC -- FDA 483: 6 observations (2025-03-28)
- Event date
- 2025-03-28 00:00:00Z
- Observed
- 2026-07-12 22:32:27Z
- Source ID
- 3016710931-2025-03-28-186290
- Payload hash
- 8778b86d3de340e364e0403e…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. Specifically, A) On March 17, 2025, you...
Entities
Informational only. Not legal, financial, or medical advice.