# FDA 483 - Santosh M. Nair, MD - February 26, 2020

Source: https://www.globalkeysolutions.net/records/483/santosh-m-nair-md/15b61f59-97d7-447f-a8e7-ed289832afb4

> FDA 483 for Santosh M. Nair, MD on February 26, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Santosh M. Nair, MD
- Inspection Date: 2020-02-26
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Santosh M. Nair, MD, Clinical Investigator, revealed significant deviations in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan and statement of investigator, maintain adequate drug disposition records, and ensure complete and accurate case histories for study subjects. These findings indicate a lack of control over critical aspects of clinical trial conduct.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/traci-m-armand/3af556f9-942c-4e58-85ee-f7d261a236ce)

Company: https://www.globalkeysolutions.net/companies/santosh-m-nair-md/bbab908a-9a0b-4728-b428-8757deef7358

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6