FDA 483 - Rohrer Aesthetics Inc. - February 21, 2025

An FDA inspection of Rohrer Aesthetics Inc. in Homewood, AL, a manufacturer of medical devices including Class II and Class IV lasers, revealed significant procedural deficiencies. The firm was cited for inadequate procedures for finished device acceptance, lacking device history record procedures, failing to follow its own training procedures, and not establishing rework procedures for nonconforming products. These issues indicate a lack of robust quality system controls.