CBI Laboratories, Inc. dba Voyant Beauty LLC. – FDA 483, Dec 5, 2017

CBI Laboratories, Inc. in Fort Worth, TX, a manufacturer of OTC human topical drug products, was cited for significant deficiencies during an FDA inspection. Observations included failures in quality control unit responsibilities, inadequate finished product and bulk material testing, non-adherence to stability testing programs, and a lack of process and packaging validation studies. These issues indicate a systemic failure to ensure product quality, identity, strength, and purity.