FDA Inspection
SRI Healthcare dba NOVO Health ServicesSRI Healthcare dba NOVO Health Services – FDA Inspection, Oct 4, 2012
Record Details
This FDA Inspection record concerns SRI Healthcare dba NOVO Health Services, with an inspection on October 4, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 4, 2012
- Product Type
- Devices
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ID · db415362-9ed9-4ec7-bd29-e1f2b62a9023
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 801842
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SRI Healthcare dba NOVO Health Services
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 15, 2026 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 18, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 22, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 30, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 27, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SRI Healthcare dba NOVO Health Services
- FDA Inspection 1341256 - 2026-10-15
- FDA Inspection 1222568 - 2023-10-18
- FDA Inspection 979661 - 2016-06-22
- FDA Inspection 938550 - 2015-07-30
- FDA Inspection 769333 - 2012-02-27
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