FDA 483 - Alembic Research Centre, Bioequivalence Facility, Alembic Pharmaceuticals, Ltd. - May 07, 2025

The FDA conducted an inspection of Pratik Doshi, M.D.'s Bioequivalence Clinical Testing Facility, part of the Alembic Research Centre in Vadodara, Gujarat, India, from March 3 to March 7, 2025. The inspection identified a significant observation related to the general requirements for informed consent. Specifically, the facility failed to ensure that consent was sought under circumstances minimizing the possibility of coercion or undue influence on study participants. A key finding involved the informed consent forms for all 60 subjects in a clinical study. These forms erroneously included the statement: "This study is a clinical research project, but no part of it is of an experimental nature." This phrasing is problematic as it could misrepresent the experimental nature of the research, potentially affecting subjects' voluntary participation. These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, highlight a need for improved adherence to regulations governing human subject protection in clinical trials. While the document does not specify immediate "required actions," the facility is expected to discuss any objections or submit plans for corrective actions to the FDA to rectify the identified deficiencies and ensure regulatory compliance.