Vedic Lifesciences Pvt. Ltd. — FDA Warning Letter Findings

The final reports for studies (b)(4) did not accurately identify the storage location for all specimens, raw data, and final reports. Specifically, before submitting the final reports to the sponsor, Vedic changed the final reports to falsely identify Vedic as the storage location; however, all specimens, raw data, and final reports were stored at (b)(4) for studies (b)(4) , and at (b)(4) for Study (b)(4) , the testing facilities that actually performed these studies.

The study directors for studies (b)(4) and (b)(4) did not sign the final reports for these studies. In accordance with 21 CFR 58.33, the study director is the individual responsible for the overall conduct of the study. For these three studies, Vedic personnel signed the final reports. However, the Vedic personnel who signed the final reports were not involved in the conduct of these studies because the studies were performed at other testing facilities. Therefore, the Vedic…

The final reports for studies (b)(4) did not include the correct names of the study director and other scientists or professionals involved in the study, such as the quality assurance unit (QAU) personnel. Specifically, before submitting the final reports to the sponsor, Vedic changed the final reports provided by the testing facilities that performed the study to falsely include the names of Vedic personnel as the study director or QAU personnel.

The final reports for studies (b)(4) did not accurately identify the testing facility that performed the studies. Specifically, the testing facility that performed studies (b)(4) was (b)(4) ( (b)(4) ), and the testing facility that performed Study (b)(4) was (b)(4) ( (b)(4) ). However, before submitting the final reports to the sponsor, Vedic changed the final reports to falsely include the name and address of Vedic as the testing facility that performed the study.