FDA Inspection
Therasage, LLC.Therasage, LLC. – FDA Inspection, Jun 19, 2013
Record Details
This FDA Inspection record concerns Therasage, LLC., with an inspection on June 19, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Therasage, LLC.
- Inspection Date
- June 19, 2013
- Product Type
- Drugs
View Company Profile
ID · ce3b6309-b558-4fe5-8ff6-3fd9a95438f5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 836088
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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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 |
| August 18, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 13, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Therasage, LLC.
- FDA Inspection 942749 - 2015-09-18
- FDA Inspection 744357 - 2011-08-18
- FDA Inspection 558307 - 2009-01-13
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