# FDA 483 - Smitha Reddy, M.D. - August 20, 2021

Source: https://www.keypedia.com/records/483/smitha-reddy-md/ecaabb3c-c95f-4186-b127-9b593d60cbdd

> FDA 483 for Smitha Reddy, M.D. on August 20, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smitha Reddy, M.D.
- Inspection Date: 2021-08-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Smitha Reddy, M.D. in Poway, CA, revealed significant deficiencies in the conduct of clinical investigations across multiple protocols. The firm failed to adhere to investigational plans, maintain adequate and accurate case histories, and ensure proper informed consent. These issues indicate a lack of control over study procedures, subject eligibility, investigational product management, and adverse event reporting, compromising the integrity of the clinical trial data.

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.keypedia.com/companies/smitha-reddy-md/a2babe9a-7e36-4b14-8e71-782cfe59d225

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