# FDA 483 - Olga M. Lapeyra, M.D. - October 25, 2021

Source: https://www.keypedia.com/records/483/olga-m-lapeyra-md/cc20d587-7c8e-4143-9868-c70123b84fa8

> FDA 483 for Olga M. Lapeyra, M.D. on October 25, 2021. 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: 2021-10-25
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Olga M. Lapeyra, M.D., Clinical Investigator, revealed significant deficiencies in the conduct of a clinical study. The firm failed to maintain adequate case histories, specifically regarding investigational product dosage documentation for multiple subjects. Additionally, the investigation was not conducted according to the protocol, as the firm did not properly monitor and report temperature excursions for the investigational product.

## Related Documents

- [EIR - 2021-10-25](https://www.keypedia.com/records/eir/olga-m-lapeyra-md/a4978617-c36e-4ffa-8f59-5da092a97fe6)
- [483 - 2024-06-07](https://www.keypedia.com/records/483/olga-m-lapeyra-md/f592d1a7-53fd-4436-9982-bf2b4d9f8a29)

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-f-duff/7efbc61c-5f7a-4d2c-86d9-500291ee6789)

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