FDA 483 - Eriochem SA - May 08, 2026

Eriochem S.A., a sterile drug product manufacturer in Parana, Argentina, was cited for significant deficiencies in its aseptic processing operations. The inspection revealed failures in thoroughly investigating discrepancies, validating aseptic and sterilization processes, and maintaining an adequate environmental monitoring program. These issues indicate a lack of robust contamination control and quality assurance for sterile drug products.