# FDA 483 - Veeda Clinical Research Pvt. Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/veeda-clinical-research-pvt-ltd/9b6b0cbd-88b4-416a-9e75-b608264e6105

> FDA 483 for Veeda Clinical Research Pvt. Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Veeda Clinical Research Pvt. Ltd.
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Veeda Clinical Research Pvt. Ltd.'s Biopharmaceutics Clinical Facility in Ahmedabad, India, revealed issues with informed consent documents. Specifically, the documents were not written at a level subjects could comprehend, and their Gujarati translation was not direct, including additional explanations not found in other language versions. These findings indicate deficiencies in ensuring adequate informed consent for clinical study participants.

## Related Documents

- [EIR - 2017-03-24](https://www.keypedia.com/records/eir/veeda-clinical-research-pvt-ltd/36b3585b-7a33-4b00-9033-6dcd57bbc83d)

## Related Officers

- [Janete F. Guardia](https://www.keypedia.com/people/janete-f-guardia/2405f83f-7ea9-4056-afbd-7d9c00a6e169)
- [investigator](https://www.keypedia.com/people/courtney-n-long/32118415-bc77-4ac2-8f90-947e43cf10ff)

Company: https://www.keypedia.com/companies/veeda-clinical-research-pvt-ltd/c16a1a7a-496e-480e-ab73-789a5e4eadf8

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8