Overview
- Federal prosecutors allege a 'manto de cobertura estatal' that let HLB Pharma and Laboratorios Ramallo continue producing and distributing adulterated fentanyl linked to roughly 90 deaths and more than 40 serious injuries.
- Last week two former regulators — ex‑ANMAT chief Nélida Bisio and ex‑INAME head Gabriela Mantecón Fumadó — were detained and later released on bail while the judicial probe continues in La Plata.
- INAME inspection reports from November–December 2024 documented structural and quality‑control failings at Laboratorios Ramallo and identified contaminated lots N°31.202 and N°31.244 tainted with Klebsiella pneumoniae and/or Ralstonia mannitolilytica.
- Prosecutors say documentary evidence and private conversations show regulators knew of the health risk but delayed or failed to issue timely warnings or block production, and the court file includes references that have raised political concern about Health Minister Mario Lugones.
- The case targets the García family‑controlled companies HLB Pharma Group S.A. and Laboratorios Ramallo S.A., has intensified calls for a formal law to regulate ANMAT, and may spur further criminal and administrative actions as investigators and the Procuraduría de Investigaciones Administrativas continue their review.