OR WAIT null SECS
The district court ordered Pick and Pay Inc./Cili Minerals to cease operations after it unlawfully manufactured and distributed unapproved new drugs, misbranded drugs, adulterated dietary supplements, and misbranded dietary supplements.
On Feb. 17, 2017, US District Judge Robert G. James for the US District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a manufacturer and distributor of drugs and dietary supplements, and its owner, Anton S. Botha, requiring the business to immediately cease operations until it comes into compliance with federal laws, FDA said in a statement. The complaint, filed by the US Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements, and misbranded dietary supplements. The company and its owner marketed their products online and also sold their products through a retail location in Lafayette, Louisiana.
According to FDA, the agency has inspected Pick and Pay Inc./Cili Minerals four times since 2012. During the inspections, FDA found Pick and Pay Inc./Cili Minerals was manufacturing and distributing misbranded and unapproved new drugs as well as misbranded and adulterated dietary supplements. The defendants marketed their products with claims that they could treat medical conditions such as cancer, cardiovascular disease, multiple sclerosis, autism, bipolar disorder, brain injury, and epilepsy. FDA has not approved Pick and Pay Inc./Cili Minerals’ drugs for any use.
During the inspection, FDA investigators also found numerous violations of the agency’s current good manufacturing practice (cGMP) regulations for dietary supplements, including failing to establish specifications for dietary supplement components and failure to test or verify that components and finished products meet product specifications for identity, purity, strength, or composition. Because the defendants failed to follow cGMP regulations, their dietary supplements are adulterated under the Federal Food, Drug, and Cosmetic Act. In May 2015, FDA issued a Warning Letter to Pick and Pay Inc./Cili Minerals for similar violations.
The consent decree prohibits the company and its owner from marketing and distributing misbranded or unapproved new drugs and adulterated or misbranded dietary supplements. Before the company and its owners can resume operations, they must, among other things, recall and destroy their existing stock of drugs and dietary supplements, hire labeling and GMP experts, and receive written permission from FDA to resume operations.