# FDA 483 - Mohammed Ansari - September 16, 2021

Source: https://www.keypedia.com/records/483/mohammed-ansari/87083e1a-f786-42a6-9e15-b4126ade16ca

> FDA 483 for Mohammed Ansari on September 16, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mohammed Ansari
- Inspection Date: 2021-09-16
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Texas Tech University Health Sciences Center in Lubbock, TX, identified a significant issue with the timely reporting of Serious Adverse Events (SAEs). The clinical investigator failed to adhere to the investigational plan and internal procedures, resulting in multiple instances of delayed SAE reporting to the Institutional Review Board (IRB). This indicates a lapse in human subject protection protocols.

## Related Officers

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

Company: https://www.keypedia.com/companies/mohammed-ansari/5086e430-f4ed-47f1-991b-8d984f999c74

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