FDA 483 - L'OREAL USA, INC. - June 24, 2022

L'OREAL USA, INC. in N Little Rock, AR, an OTC drug and cosmetic manufacturer, was cited for three observations during an FDA inspection. The firm failed to follow quality control unit procedures regarding record keeping and retention, did not perform routine equipment calibration within established timeframes, and lacked proper documentation for second-person review of cleaning logs. These issues indicate deficiencies in the firm's quality system and adherence to its own written procedures.