# FDA 483 - Piangwarin Phaosawasdi, M.D. - May 18, 2023

Source: https://www.globalkeysolutions.net/records/483/piangwarin-phaosawasdi-md/98ad142e-704c-4fde-8ef2-ebf63e69dbbd

> FDA 483 for Piangwarin Phaosawasdi, M.D. on May 18, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Piangwarin Phaosawasdi, M.D.
- Inspection Date: 2023-05-18
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Amicis Research Center in Vacaville, CA, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to study protocols, ensure proper informed consent for Spanish-speaking patients, maintain accurate case histories, and promptly report adverse events to both the IRB and the study sponsor. These issues highlight critical lapses in patient safety and regulatory compliance.

## Related Officers

- [Scott N. Lim](https://www.globalkeysolutions.net/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.globalkeysolutions.net/companies/piangwarin-phaosawasdi-md/564882c5-51cb-45ff-bf4d-50a62ea816b5

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b