FDA 483 - Lifetech Resources, LLC - April 05, 2019

An FDA inspection of Lifetech Resources, LLC in Moorpark, CA, an OTC drug and cosmetic manufacturer, identified two significant observations. The firm failed to establish and follow written procedures for equipment cleaning and maintenance, specifically lacking cleaning validation for non-dedicated equipment used in OTC drug manufacturing. Additionally, the firm did not complete required annual product reviews for its OTC drug products for 2017 and 2018, indicating deficiencies in its quality system.