FDA Inspection
Rodo Medical IncRodo Medical Inc – FDA Inspection, Aug 1, 2014
Record Details
This FDA Inspection record concerns Rodo Medical Inc, with an inspection on August 1, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Rodo Medical Inc
- Inspection Date
- August 1, 2014
- Product Type
- Devices
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ID · d5a44aa1-bc6e-4273-a95d-ffd364162f97
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 888939
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
16- 21 CFR 812.46(b)(1)No evaluation of unanticipated adverse effects
- 21 CFR 812.42Sponsor began study before IRB/FDA approval
- 21 CFR 812.43(c)(2)No info on relevant experience in investigator agreement
- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.140(b)(4)(v)Sponsor records re QSR/GMP & non-significant risk studies
- 21 CFR 812.140(b)(4)(i)Sponsor records re device use in non-significant risk study
- 21 CFR 812.43(d)Monitors not qualified
- 21 CFR 812.45Sponsor provide device information to investigators
- 21 CFR 812.43(a)Investigator(s) not qualified
- 21 CFR 812.140(b)(5)Sponsor records of adverse device effects & complaints
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