FDA Inspection
THEROZONE USA, INC.THEROZONE USA, INC. – FDA Inspection, Mar 16, 2011
Record Details
This FDA Inspection record concerns THEROZONE USA, INC., with an inspection on March 16, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- THEROZONE USA, INC.
- Inspection Date
- March 16, 2011
- Product Type
- Devices
View Company Profile
ID · d1afcea9-b601-40d8-b330-12286fab24d5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 712827
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.20(a)Quality policy and objectives
Full citation text and observation details available on the Dashboard.
Other FDA inspections of THEROZONE USA, INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for THEROZONE USA, INC.
- FDA Inspection 784308 - 2012-05-31
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.