FDA 483 - World Gen, LLC - August 07, 2025

An FDA inspection of World Gen, LLC, a veterinary drug manufacturer in Hamilton, New York, revealed significant deficiencies across its manufacturing and quality control operations. Observations included failures in preventing cross-contamination, ensuring data accuracy for computer systems, validating equipment cleaning, and thoroughly investigating deviations. The firm also exhibited inadequate quality unit oversight, poor facility sanitation, and insufficient control over changes and training.