More than 300,000 dietary supplement containers, including tablets, capsules and teas from Life Rising Corporation were seized by the U.S. FDA officials. The products were seized from company’s Willowbrook, Illinois, manufacturing facility, consisted of hundreds of goods bearing brand names Holicare, or Life Rising, and their value is around $3.5 million.
The Illinois District Court determined that the dietary supplements prepared, packed or held by the company were seized due to non-compliance with current good manufacturing practice (cGMP) requirements.
Apart from cGMP violation, the company was also found guilty for not establishing specifications for identity, purity, strength, and composition of finished batches of dietary supplement and for limits on contamination, to ensure product quality. Written procedures for pest control, cleaning and sanitizing equipment were also not available.
Last month, the FDA issued an Administrative Detention Order to prevent these product’s sales until they could be seized. They also issued a safety alert for three Life Rising products due to lead contamination and the company recalled those products.
FDA now discourages consumers from using these products due to recalls, safety alerts and continuous cGMP violations.
Mr Vinod Arora, Principal Advisor, IGMPI
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