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Posted March 31, 2018

Supplement Manufacturer Shut Down for Manufacturing Violations

On March 29, 2018, the FDA announced that U.S. District Court for the Eastern District of New York has entered a consent decree of permanent injunction with Riddhi USA, Inc. and Mohd M. Alam, president and owner of Riddhi USA, Inc., for selling adulterated and misbranded dietary supplements. The injunction requires company to stop directly or indirectly manufacturing or distributing dietary supplements.

In 2016, Riddhi USA received a warning letter from the FDA that detailed manufacturing violations that caused its products, including its Prenatal Formula Tablets, Neuroxygen Capsules, Formula For Men Capsules, and Mulberry Leaf Capsules to be adulterated. These violations included failure to establish and follow written procedures for the responsibilities of the quality control operations, and failure to include complete information relating to the production and control of each batch of dietary supplements in batch production records, as required by federal regulations.

(See's Review of Multivitamin and Multimineral Supplements for tests of related products.)

In the FDA's news release about the injuction, the FDA's associate commissioner for regulatory affairs Melinda Plaisier stated, "Dietary supplement companies put the public's health at risk when they repeatedly fail to follow good manufacturing practice regulations and omit required information about the product in their labeling. The FDA will continue to take action to protect the American public when companies violate the law."

Riddhi USA is a manufacturer that distributed dietary supplements wholesale. The company does not market or advertise under its own brand. 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.

See Related Warnings:

Federal Court Shuts Down Seller of Supplement Promoted for Herpes

FDA Warns: Beware of Bogus STD Products

Maker of Herbal Supplements Sold on eBay, Amazon and Other Websites Shut Down

Company Ordered to Stop Making and Selling Supplements

Supplement Maker Ordered to Stop Selling Products

To read the FDA's press release, use the link below.