In a March 29, 2018 press release, the Food and Drug Administration (FDA) announced a consent decree entered by the US District Court for the Eastern District of New York for a permanent injunction against Riddhi USA and its owner, Mohd M. Alam.  Riddhi USA (which is not currently manufacturing dietary supplements) is a New York based wholesale manufacturer and distributor of dietary supplements.  The permanent injunction requires the defendants to cease directly or indirectly manufacturing or distributing dietary supplements.

In 2016, the FDA issued a warning letter to Riddhi USA after a facility inspection identified violations of good manufacturing practice regulations and for failing to declare all ingredients on the products’ labels.

Last year, Riddhi USA was charged with violating the Federal Food, Drug, and Cosmetic Act because their products were prepared, packed or held in violation of current good manufacturing practice regulations (cGMP).  The violations included failing to establish product specifications for the identity, purity, strength and composition of the finished dietary supplements; inadequate master manufacturing and batch production records; lack of quality control procedures; and lack of procedures to investigate product complaints.  Additionally, the products’ labeling failed to declare dietary ingredients, allergens and the manufacturer’s place of business.

Should Riddhi USA or Mr. Alam wish to begin manufacturing again, the consent decree prohibits Riddhi USA 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.