California dietary supplement maker, Custompax prohibited from manufacturing
Magistrate Judge Susan van Keulen for the U.S. District Court for the Northern District of California entered a consent decree of permanent injunction between the United States and Custompax Inc. of Freemont, California, and its Chief Executive Officer, Secretary, Chief Financial Officer and owner Cedric Ling.
According to the complaint filed with the consent decree, Custompax manufactured and sold customized dietary supplements directly to websites where physicians and health care practitioners created and ordered their own unique dietary supplements by selecting the type and quantity of ingredients as well as custom labels or unique names.
The complaint, filed by the U.S. Department of Justice on behalf of the FDA, sought a permanent injunction against Custompax for multiple violations of the current good manufacturing practices (cGMP) regulations for dietary supplements, including the failure to adequately establish identity specifications for each component used in the manufacture of finished dietary supplements; the failure to establish component specifications to ensure the finished product meets specifications for purity, strength, and composition; the failure to establish product specifications for the identity, purity, strength, composition of the finished batch of dietary supplement; and the failure to conduct appropriate tests or examinations to determine compliance with specifications for identity, purity, strength, and composition.
“Companies that repeatedly violate cGMP regulations put consumers
at risk for harm, as well as mislead consumers regarding product ingredients
which they think they are paying for,” said Melinda Plaisier, FDA’s
associate commissioner for regulatory affairs. “While voluntary
compliance is something that the agency strives for, actions like these
are necessary for those that simply cannot adhere to regulations.”
Custompax is not currently manufacturing any dietary supplements. Should they wish to begin manufacturing again, the consent decree prohibits Custompax from receiving, processing, manufacturing, preparing, packing, holding and distributing dietary supplements until they hire an expert to ensure that they are following all cGMP regulations and following an inspection, receive FDA approval to resume operations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.