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2h ago

ANMAT Suspends Polybius Laboratory’s Production Under Disposición 7355/2025

Provincial findings tying the Rosario site to an already inhibited client prompted ANMAT’s preventive shutdown for quality‑control failures.

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La Anmat suspendió las actividades productivas de un laboratorio por fabricar especialidades medicinales para una firma inhibida
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Overview

  • The order, published Tuesday in the Official Gazette, halts Laboratorios Polybius from producing, fractioning, or distributing medicines until corrective actions are verified.
  • The inspection was triggered after P. L. Rivero y Cía. S.A. was previously inhibited under Disposición 6199/25, with Polybius listed as a contract manufacturer for that firm.
  • Polybius acknowledged producing two 500 ml saline lots (70413108 and 70416108) in December 2024 during the on-site verification.
  • Inspectors noted delays in raw‑material log entries, unsigned analysis protocols, and expired area qualifications, deficiencies ANMAT said undermine traceability and recall readiness.
  • ANMAT opened a sanitary sumario against the company and its technical director and notified INAME and provincial authorities, marking roughly the seventh lab inhibition in about a month.