# FDA 483 - Brian Flowers - March 23, 2023

Source: https://www.keypedia.com/records/483/brian-flowers/dff688f0-3e55-4d7f-b24f-36d283c6524e

> FDA 483 for Brian Flowers on March 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brian Flowers
- Inspection Date: 2023-03-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Brian Flowers, a clinical investigator in Fort Worth, TX, revealed a significant deviation from the investigational plan. The site failed to properly monitor and report temperature excursions for study medication, resulting in two subjects receiving investigational product that was not stored under appropriate conditions. This indicates a failure to adhere to protocol requirements for clinical investigations.

## Related Officers

- [Joanne M. Schlossin](https://www.keypedia.com/people/joanne-m-schlossin/5cb48b8a-d885-4b4f-8c60-d4714d65603d)

Company: https://www.keypedia.com/companies/brian-flowers/d54b9c67-97e2-40d1-a4ff-f6bd77cdc630

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab