# FDA 483 - Parvez Mantry - November 14, 2023

Source: https://www.keypedia.com/records/483/parvez-mantry/2120ba30-a661-48c1-a43e-9525f78d5fb7

> FDA 483 for Parvez Mantry on November 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Parvez Mantry
- Inspection Date: 2023-11-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of The Liver Institute at Methodist Dallas, a clinical investigator site, revealed a significant deficiency in their investigational plan. The firm failed to report Serious Adverse Events (SAEs) to the sponsor or designee within the required 24-hour timeframe, as stipulated by their own protocol. This lapse in timely reporting was observed across multiple study subjects, indicating a failure to adhere to critical safety reporting procedures.

## Related Officers

- [Joanne M. Schlossin](https://www.keypedia.com/people/joanne-m-schlossin/5cb48b8a-d885-4b4f-8c60-d4714d65603d)
- [Terri E. Gibson](https://www.keypedia.com/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)

Company: https://www.keypedia.com/companies/parvez-mantry/05f76fe9-2d00-4c3e-9ca8-84629a673238

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