FDA 483 - Lumene Oy - August 26, 2022

Lumene Oy, an OTC drug and cosmetic manufacturer in Espoo, Finland, was cited for significant deficiencies during an FDA inspection. Observations included inadequate equipment cleaning and maintenance, incomplete cleaning validation, failure to investigate product quality issues and OOS results, and insufficient microbiological testing for pathogens. Additionally, the firm failed to follow laboratory control mechanisms, properly validate supplier COAs, and conduct annual visual inspections of reserve samples, with the latter being a repeat observation.