FDA Inspection
Spinalight, Inc.Spinalight, Inc. – FDA Inspection, Jul 19, 2012
Record Details
This FDA Inspection record concerns Spinalight, Inc., with an inspection on July 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spinalight, Inc.
- Inspection Date
- July 19, 2012
- Product Type
- Devices
View Company Profile
ID · 9ffb2255-3eae-4fb3-962d-3281958e4735
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 792598
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spinalight, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 19, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 18, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Spinalight, Inc.
- FDA Inspection 1228191 - 2024-01-31
- FDA Inspection 919385 - 2015-03-19
- FDA Inspection 740084 - 2011-08-18
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