FDA 483 - Creative Essences Inc - September 04, 2020

Creative Essences Inc, an OTC drug product manufacturer in Santa Fe Springs, CA, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight a systemic lack of adequate procedures and documentation across critical areas including employee training, complaint handling, investigations, equipment maintenance, facility repair, process validation, batch records, laboratory controls, stability testing, raw material management, and labeling controls. These issues indicate a severe lack of adherence to cGMP requirements, potentially impacting drug product quality, safety, and purity.