FDA 483 - DyAnsys India Pvt. Ltd. - December 15, 2022

DyAnsys India Pvt. Ltd. in Chennai, India, a medical device sponsor, was cited for failing to assure a single-site clinical trial was conducted in accordance with Good Clinical Practice. The inspection revealed significant issues including lack of informed consent documentation, failure to follow the investigational plan, inadequate monitoring, and insufficient training and record-keeping for study devices. These deficiencies indicate a serious lack of control over the clinical trial process.