FDA 483 - Lifetech Resources, LLC - March 03, 2025

An FDA inspection of Lifetech Resources, LLC, a contract drug manufacturer, revealed significant deficiencies in current good manufacturing practices. Observations included inadequate employee training documentation, insufficient control over drug product labeling, improper reserve sample quantities for active pharmaceutical ingredients, and a lack of consistent temperature and humidity monitoring in the warehouse. These issues indicate a need for improved quality control and adherence to regulatory standards.