FDA Inspection
SmartSurg Medical Supply LLCSmartSurg Medical Supply LLC – FDA Inspection, Sep 11, 2017
Record Details
This FDA Inspection record concerns SmartSurg Medical Supply LLC, with an inspection on September 11, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 3c2754ee-6fe6-4904-915e-40d297b67e61
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024816
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.265(a)Evaluation--microorganisms, damage
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.270(d)Retention time (10 year rules)
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of SmartSurg Medical Supply LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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