FDA Inspection
Advanced Imaging Research Inc, DBA Sree Medical SystemsAdvanced Imaging Research Inc, DBA Sree Medical Systems – FDA Inspection, Jun 2, 2009
Record Details
This FDA Inspection record concerns Advanced Imaging Research Inc, DBA Sree Medical Systems, with an inspection on June 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 2, 2009
- Product Type
- Devices
View Company Profile
ID · c1e44c5d-18b8-41aa-9bd8-9e115cadc156
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 581483
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.100(a)(4)Verify, validate change {see also 820.100(a)}
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Advanced Imaging Research Inc, DBA Sree Medical Systems
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 15, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Advanced Imaging Research Inc, DBA Sree Medical Systems
- FDA Inspection 1049448 - 2018-04-11
- FDA Inspection 755551 - 2011-12-15
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.