FDA 483 - Circadia by Dr Pugliese, Inc. - April 01, 2022

Circadia by Dr Pugliese, Inc. in Leesport, PA, an OTC drug manufacturer, was cited for multiple significant deficiencies in its quality system. The inspection revealed a lack of validated manufacturing processes, stability testing programs, cleaning validation, supplier CoA verification, finished product testing, and annual product reviews for its drug products, including sunscreen. These issues indicate a severe lack of fundamental controls for ensuring drug product quality and purity.