FDA Inspection
Alan Neuromedical TechnologiesAlan Neuromedical Technologies – FDA Inspection, Nov 5, 2014
Record Details
This FDA Inspection record concerns Alan Neuromedical Technologies, with an inspection on November 5, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 5, 2014
- Product Type
- Devices
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ID · 35a14c46-77e6-41b6-8621-ab96765f5b20
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 904809
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(b)(4)Availability of records of non-significant risk studies
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
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Other FDA inspections of Alan Neuromedical Technologies
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 8, 2011 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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