FDA WARNING_LETTER - Unknown Company - March 07, 2025

Alembic Pharmaceuticals Ltd. received a formal warning letter from the U.S. Food and Drug Administration (FDA) following an inspection of its Bioequivalence Facility in Gujarat, India, conducted from March 3 to 7, 2025. The investigation focused on the company’s conduct during a clinical study and identified serious failures in protecting the rights and safety of research participants. The primary issue was the company’s failure to obtain proper informed consent. The FDA found that the Informed Consent Form contained misleading language, stating the study was not experimental. Because bioequivalence studies are classified as experiments, this description was inaccurate and could have influenced individuals to participate without fully understanding the nature of the research. These actions violated the Federal Food, Drug, and Cosmetic Act and federal regulations (21 CFR Parts 50 and 312) governing clinical investigations. While Alembic initiated some corrective measures, such as updating internal procedures and templates, the FDA deemed these efforts insufficient. Specifically, the clinical investigator lacked documented training on federal research regulations, and the company failed to provide copies of the newly approved consent forms. Alembic must respond within 15 business days with a detailed plan to ensure future compliance and provide evidence that all deficiencies have been corrected. Failure to address these concerns may lead to further regulatory action.