FDA Inspection
Skanray Technologies Pvt. LtdSkanray Technologies Pvt. Ltd – FDA Inspection, Dec 6, 2012
Record Details
This FDA Inspection record concerns Skanray Technologies Pvt. Ltd, with an inspection on December 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 6, 2012
- Product Type
- Devices
View Company Profile
ID · 339f809f-d2f1-47d9-a367-acb2cd841583
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 815162
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Skanray Technologies Pvt. Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Skanray Technologies Pvt. Ltd
- FDA Inspection 676524 - 2010-06-25
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.