N.Y. Dietary Supplement Manufacturer Recalls Products Under Consent Decree

<p>An FDA inspection last year revealed &#8220;significant deviations" from the cGMPs, according to the Justice Department.</p>

WASHINGTON—A Lindenhurst, New York-based manufacturer of dietary supplements has been permanently enjoined from operating and must recall all products sold since Jan. 1, 2014 under a consent decree signed by a federal court, the U.S. Justice Department announced Thursday.

In a complaint filed July 21 in the U.S. District Court for the Eastern District of New York, prosecutors alleged Applied Polymer Systems dba APS Pharmaco (APS) and its president, Nuka Reddy, manufactured and distributed “adulterated" supplements in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).

An FDA inspection last year revealed “significant deviations" from cGMPs (current Good Manufacturing Practices), according to the Justice Department. Among other alleged infractions, an FDA inspector cited the company for failure to verify the identity of each component that is a dietary ingredient through testing or examination, and failure to establish product specifications for the identity, purity, strength and composition of finished batches of dietary supplements. During an inspection the previous year, FDA cited APS for a number of the same or similar infractions, according to the lawsuit.

The consent decree bars the company from resuming operations unless FDA has determined that its manufacturing practices are in compliance with the law.

Reddy did not immediately return a phone call seeking comment on the consent decree.

TAGS: Litigation
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