FDA 483 - Eco Lips, Inc. - July 14, 2023

An FDA inspection of Eco Lips, Inc. in Cedar Rapids, IA, a human drug manufacturer, revealed significant deficiencies in production and process control procedures and documentation. The firm failed to consistently follow written procedures for line clearance and sample collection, and did not adequately investigate out-of-specification results or incorrect labeling incidents, with one observation being a repeat finding. These issues indicate a lack of robust quality control and adherence to manufacturing standards.