# FDA 483 - Richard J. Obiso, PhD dba Avila Herbals, LLC - July 26, 2021

Source: https://www.keypedia.com/records/483/richard-j-obiso-phd-dba-avila-herbals-llc/f87a4d5e-4824-4901-8549-eba035243706

> FDA 483 for Richard J. Obiso, PhD dba Avila Herbals, LLC on July 26, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Richard J. Obiso, PhD dba Avila Herbals, LLC
- Inspection Date: 2021-07-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Richard J. Obiso, PhD dba Avila Herbals, LLC, a sponsor-investigator in Christiansburg, VA, was inspected regarding a clinical investigation involving the investigational drug Oleander 4X. The inspection revealed significant deficiencies across multiple areas of clinical trial conduct. These include failure to submit an IND, lack of IRB review and approval, inadequate informed consent processes, and poor record-keeping for adverse events, protocol deviations, and drug accountability.

## Related Documents

- [WARNING_LETTER - 2021-07-26](https://www.keypedia.com/records/warning_letter/richard-j-obiso-phd-dba-avila-herbals-llc/3c23df9a-464f-48ee-ba7f-af32f07d0290)

## Related Officers

- [investigator](https://www.keypedia.com/people/melanie-n-daniels/51d7ddf0-f1af-4e42-ba4c-9a18200f42a9)

Company: https://www.keypedia.com/companies/richard-j-obiso-phd-dba-avila-herbals-llc/10234e7c-bb82-46b0-ae46-48b9342c3294

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e