FDA Inspection
Therasage, LLC.Therasage, LLC. – FDA Inspection, Jan 13, 2009
Record Details
This FDA Inspection record concerns Therasage, LLC., with an inspection on January 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Therasage, LLC.
- Inspection Date
- January 13, 2009
- Product Type
- Devices
View Company Profile
ID · 556470f6-dc60-49d7-826b-c0e34d277a3e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 558307
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.198(e)(6)Results of investigation
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Therasage, LLC.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 19, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Therasage, LLC.
- FDA Inspection 942749 - 2015-09-18
- FDA Inspection 836088 - 2013-06-19
- FDA Inspection 744357 - 2011-08-18
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