Products are unapproved and adulterated
SILVER SPRING, Md., Oct. 27 /PRNewswire-USNewswire/ -- At the request of the U.S. Food and Drug Administration, U.S. Marshals seized articles of prescription and over-the-counter (OTC) drug products from Tri-Med Laboratories Inc. in Somerset, N.J. earlier this month. The seizure warrant issued by the U.S. District Court for the District of New Jersey and unsealed this week, shows the drugs are unapproved and adulterated new drugs.
The drug products manufactured and distributed by Tri-Med are unapproved new drugs under the Federal Food, Drug and Cosmetic Act and therefore are not permitted to be introduced into interstate commerce. The products have not been proven safe and effective for their intended use.
The seized products are adulterated because they were manufactured under conditions not in compliance with current Good Manufacturing Practice (cGMP) to assure that they meet the identity, quality, and purity standards they claim to possess.
"The FDA is taking this action because Tri-Med has refused to take these unapproved products off the market after it received warning letters and regulatory meetings," said Dara Corrigan, the FDA's associate commissioner for regulatory affairs. "This action shows FDA's commitment to protecting the public health from the dangers of unapproved or adulterated drug products."
FDA inspections of Tri-Med since 1997 revealed Tri-Med continued to manufacture distribute unapproved, misbranded and adulterated drugs with significant cGMP violations.
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SOURCE U.S. Food and Drug Administration