fda_483 · inspection_citation · high
GenoGenix, LLC -- FDA 483: 16 observations (2025-07-18)
- Event date
- 2025-07-18 00:00:00Z
- Observed
- 2026-07-12 22:32:01Z
- Source ID
- 3032144832-2025-07-18-188559
- Payload hash
- 08478784eb4c2de617dc4314…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of drug products pmpo1iing to be sterile did n ot include validation of the process. Specifically, A) On 07/ 16/2025, we obs...
Entities
Informational only. Not legal, financial, or medical advice.