Overview
- This week Nélida Agustina Bisio, former head of ANMAT (Argentina’s drug regulator), gave a four-hour expansion of her judicial declaration and denied direct operational responsibility for controls over HLB Pharma and Laboratorios Ramallo.
- Prosecutors say fentanyl lots 31.202 and 31.244, produced in December 2024 and distributed from January 2025, were contaminated with Klebsiella pneumoniae and Ralstonia pickettii and are linked in the judicial file to roughly 90 deaths and dozens of severe cases.
- Court documents and inspections in the case show INAME (ANMAT’s inspection arm) recorded critical manufacturing failures at the two firms but did not order plant closures or immediate production halts, a gap now central to questions of regulatory follow-up.
- Bisio’s written 117-page defense and oral testimony shift operational blame to former INAME director Gabriela Mantecón Fumadó and seek to distance Health Minister Mario Lugones while judges and prosecutors continue to examine GDE timestamps, inspection actas, WhatsApp logs and peritajes.
- The federal probe in Juzgado Federal N.º 3 in La Plata remains active, several company executives have been detained and released on bail, and the case could reshape regulatory accountability, criminal liability for corporate directors, and oversight of hospital drug supply chains.