FDA Inspection
Focus Surgical IncFocus Surgical Inc – FDA Inspection, Oct 10, 2014
Record Details
This FDA Inspection record concerns Focus Surgical Inc, with an inspection on October 10, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Focus Surgical Inc
- Inspection Date
- October 10, 2014
- Product Type
- Biologics
View Company Profile
ID · c40038ce-7c80-47b0-b720-e6af2142f866
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 899903
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
1- 21 CFR 1271.160(a)All core requirements covered in program
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Focus Surgical Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 4, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 3, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 21, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Focus Surgical Inc
- FDA Inspection 1102686 - 2019-09-17
- FDA Inspection 993330 - 2016-11-04
- FDA Inspection 812822 - 2013-01-03
- FDA Inspection 706997 - 2011-01-21
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