Judge Robert G. James of the District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a producer and distributor of several products including drugs and dietary supplements. The owner, Anton S. Botha, was ordered to cease all business operations until he complies with Good Manufacturing Practices (GMPs).
According to an article in PharmaTech, Botha’s company came to the attention of the Food and Drug Administration (FDA) for manufacturing and distributing unapproved new drugs, misbranded/misrepresented drugs, adulterated dietary supplements, and misbranded dietary supplements. Cili Minerals also promoted their products with medical benefits and unsubstantiated marketing claims. Drugs are required to go through expensive bureaucratic red tape and clinical trials before being available for consumer use and Dietary supplements must have clinical trials to back up claims of specific benefits.
The FDA has audited Pick and Pay/Cili Minerals four times since 2012 and sent a warning letter in 2015. FDA investigators found Bothra’s company to be out of compliance with current Good Manufacturing Practices (cGMPs) regulations for dietary supplements. Among the violations, Bothra’s company failed to establish Specifications for ingredients and, were not testing or verifying ingredients and finished goods. Testing and verification are required to ensure that a product or ingredient meets the standards of purity, concentration, strength, and composition.
Pick and Pay/Cili Minerals did not address their cGMP violations so their products are classified as adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C). The injunction prohibits Bothra and his company from producing, distributing, and marketing unapproved drugs, misbranded drugs, adulterated dietary supplements, and misbranded dietary supplements. Before operations can resume, the company must destroy and dispose of existing stock. They must bring in cGMP experts and receive written permission from the FDA in order to resume production.
Pharmaceutical and Dietary Supplement companies looking to increase production automation and efficiency while improving quality and compliance should consider making the move to Electronic Batch Records (EBR). InstantGMP™ PRO is a software solution that has helped numerous manufacturers worldwide make the paper-to-electronic transition. Take a look and sign up for a live demonstration where we’ll show you the benefits of our EBR system.