Alejandra Mantecón Fumadó, former director of Instituto Nacional de Medicamentos, answered 33 times that she did not remember details of her own management during the inquiry into the contaminated fentanyl from HLB Pharma. The investigation links that product to the death of 90 patients and is being overseen by judge Ernesto Kreplak and prosecutor María Roteta. The questions sought to reconstruct what the oversight body knew, when it received the alerts, and why it did not withdraw all the compromised products sooner.
The former official is under investigation for the possibility that actions or omissions during her management may have contributed to batches with microbial contamination reaching hospitals and clinics. In the same procedural situation is Agustina Nélida Bisio, former head of ANMAT and direct superior of Mantecón Fumadó. The charge does not equate to a conviction: the file seeks to determine responsibilities within the healthcare and administrative chain.
An inspection carried out on November 28, 2024, at Laboratorio Ramallo, where fentanyl was produced, had detected records of products manufactured in unauthorized areas, unauthorized containers, and withdrawal notices that were resisted or delayed. On May 13, inspector Ana Laura Canil reported discrepancies in the documentation of the fentanyl line and questioned the analyses of lot 31202. Based on that report, INAME extended the measures to all products from Ramallo and took action against HLB for possible data falsification.
The statement also laid out an informal circuit of orders. Mantecón Fumadó said that the reports requested by the court went to Bisio, were consulted with the Ministry of Health, and returned as instructions which she then formalized. She attributed to the then minister Mario Lugones the directive to proceed cautiously and, weeks later, the order to close HLB. These statements are part of her defense and will have to be confronted with documents, communications, and testimonies incorporated into the case file.
The health chronology focused another section of the interrogation. The first death was recorded on April 14, 2025, and that day INAME received notices about adverse events; on April 22, HLB fentanyl was identified, lot 31202. Hospital Italiano de La Plata reported the quality deviation on May 2, the email was seen on the 5th, an alert was issued on the 8th, and the criminal complaint was formalized on the 12th. The prosecution maintains that prior conversations contradict parts of the alleged unawareness.
Mantecón Fumadó also described a reduced structure: she said that it went from between 18 and 20 inspectors to working with eight for about 600 laboratories, and that visits to HLB and Ramallo required police custody because the staff felt afraid. She also stated that the State verifies good practices, but does not control each individual batch. The case will have to determine whether those limitations explain the delays or whether there were specific breaches, while thirteen business leaders continue to be prosecuted and the situation of the former authorities is being defined.
