FDA Inspection
Surgical Tissue Network, Inc. dba TissueNetSurgical Tissue Network, Inc. dba TissueNet – FDA Inspection, Jun 20, 2012
Record Details
This FDA Inspection record concerns Surgical Tissue Network, Inc. dba TissueNet, with an inspection on June 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 20, 2012
- Product Type
- Devices
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ID · d2b65acc-b63c-457a-8095-3adeea36ec6b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 784704
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
18- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 1271.265(c)(3)HCT/Ps made under departure from process
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 1271.200(d)Inspected routinely
- 21 CFR 1271.170(b)Qualifications lacking
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Surgical Tissue Network, Inc. dba TissueNet
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 6, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 4, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Surgical Tissue Network, Inc. dba TissueNet
- FDA Inspection 924608 - 2015-04-30
- FDA Inspection 856417 - 2013-11-06
- FDA Inspection 649845 - 2010-03-04
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