# FDA 483 - Gershwin Blyden, M.D. - September 12, 2019

Source: https://www.globalkeysolutions.net/records/483/gershwin-blyden-md/46639e4b-df45-4fe4-a265-eb609888fdf5

> FDA 483 for Gershwin Blyden, M.D. on September 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gershwin Blyden, M.D.
- Inspection Date: 2019-09-12
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Gershwin Blyden, M.D. in Hollywood, FL, a clinical investigator, revealed significant deficiencies in the conduct of a clinical study. Observations included subjects being deemed eligible for study participation before all required screening assessments were completed, inaccurate case histories with eligibility forms signed prior to their revision date, and inadequate investigational drug disposition records with discrepancies in dispensed product bottles.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/gershwin-blyden-md/4029a7c3-0883-4547-ad50-44c6a39b0927

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