Overview

• Disposición 6245/2025, signed by ANMAT chief Nélida Agustina Bisio on Sept. 4 and published Sept. 5 in the Boletín Oficial, orders a full halt to the company’s manufacturing activities in Ciudad de Buenos Aires.
• An INAME inspection found the firm was not operating at an acceptable level of compliance with Good Manufacturing Practices.
• Inspectors recorded undeclared structural modifications and the plan to produce a first lot of Amixen, a product of Laboratorios Bernabó, in areas that lacked authorization.
• A follow-up visit on Sept. 4 found continued use of non‑habilitated sectors, and the company was told operations cannot resume until all observations are corrected and confirmed through a new inspection.
• ANMAT cited its GMP guideline (Disposición 4159/2023) and warned that producing in unauthorized conditions jeopardizes the quality, safety and efficacy of medicines.