# FDA 483 - Samuel A. Mujica Trenche, MD - August 09, 2019

Source: https://www.keypedia.com/records/483/samuel-a-mujica-trenche-md/2686452e-ab88-401c-a5fc-126052ced2e0

> FDA 483 for Samuel A. Mujica Trenche, MD on August 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samuel A. Mujica Trenche, MD
- Inspection Date: 2019-08-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Samuel A. Mujica Trenche, MD, a clinical investigator in Henderson, NV, revealed a significant compliance issue regarding informed consent. The firm failed to obtain legally effective informed consent by not re-consenting enrolled subjects when a new informed consent document was approved and available. This indicates a serious lapse in protecting human subjects in clinical trials.

## Related Officers

- [Jonathan R. Campos](https://www.keypedia.com/people/jonathan-r-campos/f4c6aba7-d0fe-43d2-95ae-5eb86a6659a4)

Company: https://www.keypedia.com/companies/samuel-a-mujica-trenche-md/0217f166-7b6d-4e37-80d3-755574a6725b

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6