# FDA 483 - Marina Nikanorova, M.D. - Unknown Date

Source: https://www.keypedia.com/records/483/marina-nikanorova-md/c7a54aa9-9cab-4d36-beee-5dfc6cfadc6d

> FDA 483 for Marina Nikanorova, M.D. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marina Nikanorova, M.D.
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: This FDA Form 483 was issued to Marina Nikanorova, M.D., a clinical investigator in Dianalund, Denmark, following an inspection related to a clinical trial for Dravet Syndrome. The inspection revealed significant deficiencies in record-keeping for efficacy endpoints, failures in obtaining informed consent under non-coercive circumstances, and improper documentation of consent forms. These issues indicate a lack of adherence to investigational plans and proper clinical trial conduct.

## Related Officers

- [Business Analyst/Provider Enrollment Specialist](https://www.keypedia.com/people/lakecha-n-lewis/39b6305d-2a9f-448b-9a14-e412b43c8522)

Company: https://www.keypedia.com/companies/marina-nikanorova-md/c26b61ea-e0da-48d0-b4d7-35d038871ce0

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4