Overview
- ANMAT, which published Disposición 2028/2026 on Tuesday, suspended Global Pharma Group’s authorization to move medicines between provinces until it proves full compliance.
- Inspectors auditing the Ramos Mejía site in early February found hygiene and building problems, including gaps that could let in insects, humidity stains, peeling paint, and missing fire‑resistant ceiling panels.
- Cold‑chain controls failed during checks, with temperatures spiking above 32°C in storage and refrigerators, alarms and sensors not responding, no thermal mapping of the warehouse, and test shipments dropping below 2°C, which can spoil sensitive drugs.
- The company could not ensure lot‑level tracking or complete paperwork, as its system did not trace by lot and invoices and dispatch notes omitted key data like active ingredient, manufacturer, expiry date, and lot number, undermining recalls and safe supply to clinics and pharmacies.
- ANMAT opened a sanitary inquiry into the firm and its technical director and kept the suspension in place, while related orders suspended Biogamma in Mendoza and stripped Ripezzi in Buenos Aires of its manufacturing good‑practice certificate with a ban on the use and sale of its imported lots.