FDA Inspection
Malcolm, Mathew PhD., OTRMalcolm, Mathew PhD., OTR – FDA Inspection, Feb 16, 2012
Record Details
This FDA Inspection record concerns Malcolm, Mathew PhD., OTR, with an inspection on February 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Malcolm, Mathew PhD., OTR
- Inspection Date
- February 16, 2012
- Product Type
- Devices
View Company Profile
ID · e20c04c8-2f74-47cf-aee3-19d9e4574ccb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 770157
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.150(b)(5)Sponsor progress reports for significant risk study
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
- 21 CFR 812.140(a)(4)Investigator record of protocol deviations inadequate
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
- 21 CFR 812.25(e)Sponsor"s lack of written monitoring procedures
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