# FDA 483 - Carlos Lastra MD - January 13, 2020

Source: https://www.keypedia.com/records/483/carlos-lastra-md/2bef8bd0-7247-495c-b00b-eb51eea0488d

> FDA 483 for Carlos Lastra MD on January 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carlos Lastra MD
- Inspection Date: 2020-01-13
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Carlos Lastra MD, a clinical investigator in New Brunswick, NJ, was cited for significant deficiencies in informed consent procedures and adherence to investigational protocols. The firm failed to provide informed consent forms in a language understandable to subjects' representatives and did not ensure subjects completed required follow-up visits or telephone contacts according to study plans. These issues indicate serious concerns regarding patient safety and data integrity in clinical trials.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.keypedia.com/companies/carlos-lastra-md/2d418225-7e69-4f01-9d04-1ef76cf08081

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248