ANMAT regulatory failures exposed in fentanyl contamination probe

A government audit report has identified severe deficiencies in the regulatory and oversight systems of Argentina’s National Administration of Drugs, Foods and Medical Technology (ANMAT) and the National Institute of Medicines (INAME). The findings have been incorporated into a judicial investigation led by Federal Judge Ernesto Kreplak regarding the deaths of 90 patients following the administration of contaminated fentanyl.

The audit revealed that the current control framework suffers from “relevant weaknesses in its design and implementation.” Key issues include the use of informal procedures, obsolete IT systems dating back to 2014, and the absence of a formal annual inspection plan. Notably, 21.7% of authorized pharmaceutical establishments had not undergone inspections for more than five years.

Specific failures were noted regarding quality deviations and market recalls. For instance, while INAME received over one hundred notifications of quality deviations from HLB Pharma Group and Laboratorios Ramallo since 2018, only a handful of inspections were conducted. Furthermore, the audit highlighted that ANMAT performed no inspections related to market withdrawals or corrections during the first half of 2025.