904809

Alan Neuromedical Technologies — FEI 3010141624

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 5, 2014
Fiscal Year
2015
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
The Woodlands, TX (United States)

Additional Details

Clinical Investigator (CI)

Citations

IDCFRDescription
292821 CFR 812.40Sponsors' general responsibilities
299121 CFR 812.140(b)(1)Sponsor correspondence records inadequate
299521 CFR 812.140(b)(4)Availability of records of non-significant risk studies
722721 CFR 50.27(a)Consent form not approved/signed/dated