FDA Warning Letter to Indian Manufacturer: Glycerine used in Manufacturing not Tested according to USP

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter dated 10 April 2023 to an Indian company, registered in the United States as a manufacturer of over-the-counter (OTC) and homeopathic drug products. Some of the company's formulations contain high percentages of glycerin, which is considered as a high-risk component.

The Warning Letter is based on a review of records and other information the firm provided on the FDA's request. Based on the documents, the FDA identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

The FDA writes that the company did not demonstrate that it tested the incoming high-risk component glycerin. According to the United States Pharmacopeia (USP), the identity testing of glycerin includes a limit test to ensure that relevant safety limits for the levels of diethylene glycol (DEG) or ethylene glycol (EG) are met. This test was not performed.

The company tested retain samples of some finished product batches for the presence of DEG and EG impurities using a test from the Indian Pharmacopeia (IP) monograph for glycerin. However, it could not be demonstrated that this test is suitable to identify the levels of DEG or EG in the finished drug product.

The FDA already placed all drugs and drug products manufactured by the firm on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"). The FDA now asked the company to provide the results of tests for DEG and EG in retain samples of all glycerin lots used in production of glycerin-containing drug products shipped to the United States.

For further information and a complete list of all the actions the FDA expects the company to take, please see the Warning Letter to Champaklal Maganlal Homeo Pharmacy Private Limited on the FDA website.