FDA 483 - Veeda Clinical Research Pvt. Ltd.

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.