FDA Inspection
MindSight Medical LLCMindSight Medical LLC – FDA Inspection, May 5, 2025
Record Details
This FDA Inspection record concerns MindSight Medical LLC, with an inspection on May 5, 2025, issued by the Dallas District Office, covering biologics.
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ID · 11e49214-906d-4165-b748-dd16cd907b95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269305
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.260(e)Temperature limits
- 21 CFR 1271.160(b)(3)Actions verified, short and long term solutions
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Other FDA inspections of MindSight Medical LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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