# FDA 483 - Sunil S. Dhawan, MD - October 07, 2015

Source: https://www.keypedia.com/records/483/sunil-s-dhawan-md/00afcadb-1eba-4360-b97c-817a17c980c8

> FDA 483 for Sunil S. Dhawan, MD on October 07, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sunil S. Dhawan, MD
- Inspection Date: 2015-10-07
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Center for Derm. Clinical Research, Inc. in Fremont, CA, revealed a significant issue with maintaining accurate case histories. The firm failed to consistently document patient complaints and adverse events from patient diaries into Case Report Forms, impacting the integrity of clinical investigation data.

## Related Officers

- [investigator](https://www.keypedia.com/people/thea-c-grome/ff1a4a19-f74c-485a-a177-f4cc5c5b7499)

Company: https://www.keypedia.com/companies/sunil-s-dhawan-md/5ad0ff3b-a312-43dc-abfc-d6078c299723

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