FDA Inspection
Spinalight, Inc.Spinalight, Inc. – FDA Inspection, Aug 18, 2011
Record Details
This FDA Inspection record concerns Spinalight, Inc., with an inspection on August 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spinalight, Inc.
- Inspection Date
- August 18, 2011
- Product Type
- Devices
View Company Profile
ID · 7ca36182-c5bd-46f0-8d27-b403849078aa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 740084
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| July 19, 2012 | 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 792598 - 2012-07-19
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