# FDA 483 - Adilia M. Hormigo, M.D. - January 08, 2020

Source: https://www.keypedia.com/records/483/adilia-m-hormigo-md/662a5d06-8375-43ba-9345-44ce474e518c

> FDA 483 for Adilia M. Hormigo, M.D. on January 08, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Adilia M. Hormigo, M.D.
- Inspection Date: 2020-01-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Adilia M. Hormigo, M.D. in New York, NY, identified a failure to ensure proper monitoring of a clinical study and adherence to the investigational plan. Specifically, the study experienced a lapse in IRB approval during which subjects received investigational vaccine products, and Quality of Life questionnaires were not performed as scheduled for several subjects. These issues indicate a lack of oversight in conducting the clinical trial.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-dan/8a8c42e4-66ec-438d-868e-f32461f9026c)

Company: https://www.keypedia.com/companies/adilia-m-hormigo-md/f9ba56ca-44de-45ad-a33c-a122b909ec5b

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961