Overview
- Biotenk S.A. was preventively inhibited after inspectors found it lacked a formal pharmacovigilance unit, had no system to capture and report adverse reactions, and failed to submit a corrective action plan.
- Laboratorios Solkotal S.A. was also inhibited for severe Good Manufacturing Practice failures, prompting ANMAT to order market recovery and prohibition of all P. L. Rivero injectables produced at that site.
- Eight laboratories and distributors lost authorization to operate due to inactivity and the absence of a designated technical director, a group that includes Laboratorio Apolo.
- ANMAT withdrew the Correo Argentino plant in Malvinas Argentinas from its role as a secondary conditioner for traceability because it lacked a required technical director.
- The regulator banned the use, sale, and distribution of two carotid stents nationwide after importer OMNIMEDICA reported the devices were stolen during transport.