FDA Inspection
Innovasis, IncInnovasis, Inc – FDA Inspection, Jun 26, 2009
Record Details
This FDA Inspection record concerns Innovasis, Inc, with an inspection on June 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Innovasis, Inc
- Inspection Date
- June 26, 2009
- Product Type
- Devices
View Company Profile
ID · 9886f5d3-9c32-4035-a4a2-f6a989da57e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 594578
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(d)Acceptance criteria and essential outputs
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.30(c)Design input procedures - addressing conflicting requirement
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
Showing 10 of 12 citations.
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Other FDA inspections of Innovasis, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 22, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 22, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Innovasis, Inc
- FDA Inspection 1102677 - 2019-08-20
- FDA Inspection 979759 - 2016-06-22
- FDA Inspection 879760 - 2014-05-22
- FDA Inspection 778886 - 2012-04-27
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