FDA WARNING_LETTER - Unknown Company - March 07, 2025

The FDA issued a Warning Letter to Dr. Pratik Doshi at Alembic Pharmaceuticals Ltd. following an inspection of the Alembic Research Centre in Gujarat, India, conducted between March 3 and 7, 2025. The inspection evaluated a clinical bioequivalence study for an investigational drug. The FDA found that the investigator failed to adhere to the Federal Food, Drug, and Cosmetic Act and regulations regarding the protection of human subjects (21 CFR Parts 50 and 312). Specifically, the investigator failed to obtain proper informed consent because the study documents inaccurately stated that the research was not experimental. This misleading language potentially prevented participants from making a fully informed decision and could have resulted in undue influence. While the company revised its internal procedures, the FDA determined their initial response was insufficient as it lacked proof of specific training on FDA regulations and copies of revised consent forms for current studies. Dr. Doshi must submit a written response within 15 business days detailing corrective actions, providing the requested documentation, and explaining how they will ensure future compliance to protect the rights and safety of clinical trial participants.