fda_483 · inspection_citation · high
Wells Pharma of Houston LLC -- FDA 483: 4 observations (2026-04-13)
- Event date
- 2026-04-13 00:00:00Z
- Observed
- 2026-07-12 22:30:41Z
- Source ID
- 3016710931-2026-04-13-192443
- Payload hash
- b5068652aa19c15ff6afff55…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of diug products pmp o1ting to be sterile are not established, written and followed. Specifically, A. Your fnm 's compoundin...
Entities
Informational only. Not legal, financial, or medical advice.