FDA Inspection
Advanced Surgicare, LLCAdvanced Surgicare, LLC – FDA Inspection, Dec 6, 2012
Record Details
This FDA Inspection record concerns Advanced Surgicare, LLC, with an inspection on December 6, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Advanced Surgicare, LLC
- Inspection Date
- December 6, 2012
- Product Type
- Biologics
View Company Profile
ID · a5c41a38-3b80-4d9a-bf3a-bb2c74bce943
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809585
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.320(c)Review and evaluation, report to FDA
- 21 CFR 1271.265(e)Documentation elements for activities
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.260(e)Periodic review of temperatures
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Other FDA inspections of Advanced Surgicare, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 10, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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