Overview
- Biotenk S.A. was inhibited from operating after INAME documented multiple pharmacovigilance breaches and the firm failed to submit a corrective and preventive actions plan on time.
- Laboratorios Solkotal S.A. was halted for severe deficiencies in staffing, quality systems, facilities and maintenance, triggering a prohibition and market recovery of all P. L. Rivero injectable lots produced at its plant.
- ANMAT also revoked the habilitation of eight establishments, including Laboratorio Apolo, citing a lack of productive activity and absence of a designated technical director as required by Law No. 16.463.
- The enforcement actions follow a leadership change at ANMAT, with Fontana replacing Agustina Bisio and reactivating resolutions that had been pending signature.
- Some entities named in the revocations have reported links to businesses referenced in a federal probe into fentanyl-contaminated lots, adding public‑health scrutiny to the compliance failures.