FDA 483 - Lavet Kft. - March 21, 2025

Lavet Kft., a drug manufacturer in Kistarcsa, Hungary, was cited for significant GMP deficiencies during a pre-approval inspection. Observations included a lack of quality unit oversight on document control and data integrity issues with laboratory software, indicating a systemic failure in maintaining reliable records. Additionally, the firm failed to ensure stability-indicating test methods, properly retain reserve samples, and qualify manufacturing equipment.