# FDA 483 - Dr. A. Sharda - April 07, 2016

Source: https://www.keypedia.com/records/483/dr-a-sharda/b7982b9c-9d1a-4ce4-8c67-6487bba8e10d

> FDA 483 for Dr. A. Sharda on April 07, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. A. Sharda
- Inspection Date: 2016-04-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of A. Sharda, M.D. in Bangalore, India, revealed significant deviations from good clinical practice during a clinical study. The firm failed to maintain adequate and accurate case histories, did not conduct the investigation according to the approved plan, and had conflicts of interest within its Ethics Committee. Additionally, the disposition of investigational product was not properly documented, indicating severe issues with data integrity and study oversight.

## Related Officers

- [investigator](https://www.keypedia.com/people/angela-shepas/743113c1-799b-44e9-9422-8049c476bfd2)
- [issuing_officer](https://www.keypedia.com/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.keypedia.com/companies/dr-a-sharda/0d5f2849-ca6c-4b09-b6b0-83c8f7892509

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd