FDA Inspection
Katerina Malagari, MDKaterina Malagari, MD – FDA Inspection, Aug 22, 2014
Record Details
This FDA Inspection record concerns Katerina Malagari, MD, with an inspection on August 22, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Katerina Malagari, MD
- Inspection Date
- August 22, 2014
- Product Type
- Devices
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ID · c354ecf9-189a-40e0-96ba-b41f98057096
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891856
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of informed consent
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