FDA 483 - OMEZA LLC - July 28, 2023

An FDA inspection of OMEZA LLC in Sarasota, FL, a drug manufacturer, revealed significant deficiencies across multiple systems. Observations included unsanitary facility conditions with mold, pests, and structural issues, as well as failures in equipment cleaning procedures. The firm also lacked adequate testing for active ingredients in finished products, stability data for OTC drugs, and proper identity testing for incoming raw materials, indicating a broad lack of quality control.