FDA Inspection
Anulex Technologies IncAnulex Technologies Inc – FDA Inspection, Sep 22, 2010
Record Details
This FDA Inspection record concerns Anulex Technologies Inc, with an inspection on September 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Anulex Technologies Inc
- Inspection Date
- September 22, 2010
- Product Type
- Devices
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ID · 42cbf0c9-fa29-47c0-875a-ffed09eef1b1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 680312
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.7(a)Promotion or test marketing
- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.43(c)No investigator agreement
- 21 CFR 812.20(a)(2)Initiation of study prior to FDA IDE approval
- 21 CFR 812.40Sponsors" general responsibilities
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Other FDA inspections of Anulex Technologies Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 8, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Anulex Technologies Inc
- FDA Inspection 835254 - 2013-05-06
- FDA Inspection 656148 - 2010-04-08
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