FDA Inspection
Sage Medical, LLCSage Medical, LLC – FDA Inspection, Jun 16, 2011
Record Details
This FDA Inspection record concerns Sage Medical, LLC, with an inspection on June 16, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Sage Medical, LLC
- Inspection Date
- June 16, 2011
- Product Type
- Biologics
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ID · 05280de9-4e47-4a98-80f5-383d5b819f9e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 731851
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.200(d)Inspected routinely
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Sage Medical, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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