FDA 483 - Clientele, Inc. - February 07, 2020

Clientele, Inc., an OTC drug manufacturer in Sunrise, FL, was cited for significant deficiencies across its quality control, laboratory controls, stability testing, equipment management, and production processes. The inspection revealed a lack of cGMP systems, inadequate testing procedures for finished products, and insufficient validation for equipment and manufacturing processes. These issues indicate a systemic failure to ensure drug product quality and purity.