# FDA 483 - Nayvis Iglesias, MD - July 29, 2021

Source: https://www.globalkeysolutions.net/records/483/nayvis-iglesias-md/83d57b4c-9c04-4d6b-b181-62b6621349d3

> FDA 483 for Nayvis Iglesias, MD on July 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nayvis Iglesias, MD
- Inspection Date: 2021-07-29
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Nayvis Iglesias, a Clinical Investigator in Coral Gables, FL, was cited for significant deficiencies during an FDA inspection. The inspection revealed that the investigator enrolled and treated subjects who did not meet the study's inclusion/exclusion criteria without proper waivers. Additionally, the firm failed to maintain accurate case histories due to transcription errors between source documents and electronic case report forms.

## Related Officers

- [Richard A. Lyght](https://www.globalkeysolutions.net/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.globalkeysolutions.net/companies/nayvis-iglesias-md/74f69745-9e46-4a94-8881-9dc10d726398

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