FDA 483 - Lavet Kft. - March 21, 2025

During an inspection conducted from March 17-21, 2025, the FDA identified significant Good Manufacturing Practice (GMP) violations at Dr. Peter Laczay's drug manufacturing facility in Kistarcsa, Hungary. The inspection revealed systemic issues with the firm's quality control unit, which lacked proper written procedures and oversight for GMP document management. Investigators found evidence of shredded critical documents, including pre-approval inspection data and draft investigations, with no adequate procedures to monitor or record document destruction, compromising data integrity.

Furthermore, the firm demonstrated inadequate computer system controls for laboratory equipment, specifically the OpenLab CDS software. This system allowed unauthorized deletion, alteration, and modification of chromatographic data without proper investigation or risk assessment. The validation of this software was also deficient. Additional observations included laboratory test procedures not being scientifically sound (e.g., an HPLC method not proven stability-indicating), failure to retain reserve drug product samples according to procedures, and unperformed Performance Qualification for critical manufacturing equipment, such as an encapsulation machine. To achieve compliance with the Federal Food, Drug, and Cosmetic Act, the company must implement comprehensive corrective and preventive actions addressing these failures in data integrity, quality oversight, and manufacturing controls to ensure product safety and efficacy.