FDA 483 - L'Oreal Usa, Inc. - September 30, 2022

Loreal USA in Florence, KY, a manufacturer of OTC drug products, was cited for multiple quality control deficiencies during an FDA inspection. Observations included failures in following procedures for water and finished product microbial testing, lack of controlled data logs, inadequate training record management, and insufficient change control for electronic data collection systems. These issues indicate a systemic breakdown in maintaining proper manufacturing controls and data integrity.