# FDA 483 - Olga M. Lapeyra, M.D. - June 07, 2024

Source: https://www.keypedia.com/records/483/olga-m-lapeyra-md/f592d1a7-53fd-4436-9982-bf2b4d9f8a29

> FDA 483 for Olga M. Lapeyra, M.D. on June 07, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olga M. Lapeyra, M.D.
- Inspection Date: 2024-06-07
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Olga M. Lapeyra, M.D., a clinical investigator in Miami Lakes, FL, revealed a significant issue regarding the conduct of an investigation. The firm failed to adhere to the signed statement of investigator and investigational plan, specifically concerning subject eligibility, availability of plasma assay reports, and documentation of medication adherence. This indicates a serious deviation from clinical trial protocols.

## Related Documents

- [EIR - 2021-10-25](https://www.keypedia.com/records/eir/olga-m-lapeyra-md/a4978617-c36e-4ffa-8f59-5da092a97fe6)
- [483 - 2021-10-25](https://www.keypedia.com/records/483/olga-m-lapeyra-md/cc20d587-7c8e-4143-9868-c70123b84fa8)

## Related Officers

- [Chantae D. Mitchell](https://www.keypedia.com/people/chantae-d-mitchell/0da68244-86f3-4119-b965-0b2dceb1c523)

Company: https://www.keypedia.com/companies/olga-m-lapeyra-md/61d3f920-9aca-42fa-a383-758a3d1f6b59

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