FDA Inspection
Advanced Medical Systems & SolutionsAdvanced Medical Systems & Solutions – FDA Inspection, Sep 27, 2011
Record Details
This FDA Inspection record concerns Advanced Medical Systems & Solutions, with an inspection on September 27, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 27, 2011
- Product Type
- Biologics
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ID · ddff6fac-ab2b-4756-95fc-9a422bc64a97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 745826
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
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