FDA 483 - Wellington Foods Incorporated - October 11, 2024

Wellington Foods Incorporated, a contract manufacturing organization in Corona, CA, was cited for significant deficiencies during an FDA inspection. The firm released OTC drug products that exceeded microbial specifications, failed to adequately validate its water system for pharmaceutical manufacturing, and did not investigate temperature excursions in its finished drug product warehouse. These issues indicate a failure to ensure drug product quality and adherence to established procedures.