FDA WARNING_LETTER - Chaotic Labz - November 17, 2014

On November 14-17, 2014, the FDA inspected Chaotic Labz, Inc.'s facility, revealing significant violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their products adulterated. As a distributor responsible for packaging, labeling, holding, and distributing dietary supplements, Chaotic Labz is ultimately accountable for ensuring CGMP compliance.

Key violations include: * Failure to implement a system of production and process controls for packaging, labeling, and holding operations (21 CFR 111.55). * Failure to establish specifications for dietary supplement labels and packaging (21 CFR 111.70(d), (g)). * Absence of written Master Manufacturing Records (MMRs) for each unique formulation and batch size (21 CFR 111.205(a)). * Failure to establish and follow written procedures for quality control operations (21 CFR 111.103, 111.65). * Failure to visually examine supplier invoices/certifications for received products (21 CFR 111.165(b)), exemplified by the "Mayhem" recall for undeclared drug ingredients. * Lack of written procedures for packaging and labeling (21 CFR 111.403), receiving products (21 CFR