FDA Inspection
Sage Medical, LLCSage Medical, LLC – FDA Inspection, Oct 26, 2012
Record Details
This FDA Inspection record concerns Sage Medical, LLC, with an inspection on October 26, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Sage Medical, LLC
- Inspection Date
- October 26, 2012
- Product Type
- Biologics
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ID · 89923a13-14df-4c74-8d5b-027061dce323
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 805117
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.265(f)Return to inventory--procedures
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Other FDA inspections of Sage Medical, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2011 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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