FDA 483 - Eriochem SA - November 05, 2019

This FDA Form 483 was issued to Eriochem SA in Parana, Argentina, following an inspection from October 28 to November 5, 2019. The inspection revealed significant deficiencies in aseptic processing, including inadequate environmental controls and procedures for preventing microbiological contamination, as well as failures in thoroughly investigating unexplained discrepancies like out-of-specification endotoxin test results. These issues indicate serious concerns regarding the firm's manufacturing practices for sterile drug products.