FDA WARNING_LETTER - Champaklal Maganlal Homeo Pharmacy Private Limited - May 23, 2023

The FDA issued a Warning Letter on May 18, 2023, to Pharmadel, LLC and CAD Import, Inc., for manufacturing, importing, and/or distributing "Bebelyn Diarrhea" and "Bebelyn Colic." The FDA determined these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Introducing or delivering these products into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act. The products are considered "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for their intended uses, which include relieving symptoms of diarrhea, colic, intestinal gas, bloating, cramping, nausea, vomiting, and hiccups in infants and young children. There are no FDA-approved applications for these products. The FDA also noted significant public health concerns due to previously identified current good manufacturing practice (CGMP) violations by the manufacturer, CMHP Private Limited, specifically regarding inadequate identity testing of high-risk glycerin, which could be contaminated with diethylene glycol (DEG) or ethylene glycol (EG). The firms are required to notify the FDA in writing within fifteen working days, detailing specific corrective actions taken to address these violations and prevent recurrence, along with supporting documentation. Failure to adequately address these issues may lead to legal action, including seizure and injunction. The letter emphasizes the firms' responsibility to comply with all federal laws and FDA regulations.