FDA 483 - Ecometics, Inc. - September 07, 2018

Ecocetics, Inc. in Norwalk, CT, an Rx and OTC drug manufacturer, received a Form 483 with nine observations. The inspection revealed significant deficiencies in contamination prevention, environmental controls for drug storage, equipment cleaning and validation, analytical method validation, and stability testing programs. Several observations were repeats, indicating persistent issues with maintaining appropriate manufacturing conditions and quality control for drug products.