# FDA 483 - Hugo Llanes JR, M.D. - May 19, 2022

Source: https://www.keypedia.com/records/483/hugo-llanes-jr-md/ff6095ce-a970-485e-bc91-26ad91e8f119

> FDA 483 for Hugo Llanes JR, M.D. on May 19, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hugo Llanes JR, M.D.
- Inspection Date: 2022-05-19
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Hugo Llanes JR, M.D., a clinical investigator in Hialeah, FL, was cited for failing to prepare and maintain adequate and accurate case histories during an FDA inspection. The report details significant data integrity issues, including inaccurate, missing, non-contemporaneous, and non-original data for multiple subjects across two clinical protocols. These deficiencies impacted critical study data, subject eligibility, and investigational product accountability.

## Related Officers

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

Company: https://www.keypedia.com/companies/hugo-llanes-jr-md/593c4f94-bb61-4ccf-b9ab-42a9e90145ad

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