Pharmaceutical

Court orders NY supplement maker to cease production

supplement Wikipedia 263x210 Court orders NY supplement maker to cease productionThe U.S. District Court for the Eastern District of New York has ordered a New York dietary supplement maker to stop selling its products until it comes into compliance with federal law and other requirements. The consent decree of permanent injunction, filed on behalf of the Food and Drug Administration (FDA), was entered against Riddhi USA Inc., and Mohd M. Alam, president and owner of the company.

Riddhi USA’s woes began after a 2016 FDA inspection which resulted in a warning letter from the agency. During that inspection, the FDA identified various manufacturing violations and failure to disclose ingredients and allergens on the company’s product labels.

Since then, the company repeatedly failed to follow good manufacturing practice regulations and omitted required information about the product in its labeling, which puts the public’s health at risk, said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA will continue to take action to protect the American public when companies violate the law.”

Riddhi USA manufacturers and distributes dietary supplements wholesale and does market or advertise them under its own brand. FDA inspectors found that the company violated the Federal Food, Drug and Cosmetic Act by failing to establish product specifications for the identity, purity, strength and composition of its supplements. The company also kept inadequate manufacturing and batch production records, lacked quality control standards and did not investigate product complaints.

Riddhi USA is not currently making dietary supplements. Should the company wish to begin manufacturing again, the consent decree prohibits it from doing so until it has come into compliance with all federal regulations, undergoes another inspection, and receives approval from the FDA.

Source: FDA News Release