FDA 483 - Eugia US Manufacturing LLC - December 22, 2023

The FDA inspected Eugia US Manufacturing LLC, a manufacturer in East Windsor, NJ, from December 11-22, 2023. The inspection revealed ten observations.

**Observation 1: Quality Control Unit Deficiencies** The quality unit is not prepared for GMP operations. It failed to adequately investigate and close quality documentation, with 16 of 34 unplanned deviations and 12 of 21 investigations remaining open, many past due. Only 1 of 14 CAPAs is closed. The firm lacks control over third-party vendors (pest control, cleaning, NetSCADA software management, HVAC qualification). The quality unit lacks access control and knowledge of NetSCADA software, unable to provide information on equipment programming or user permissions. The firm failed to establish specific procedures for planned/unplanned deviations, training, and sample submission.

**Observation 2: Aseptic Processing Area Cleaning Deficiencies** The firm failed to provide documentation supporting validation of cleaning, sanitization, and disinfection procedures for product contact surfaces in aseptic processing areas, and failed to assess the safety and effectiveness of cleaning agents.

**Observation 3: Building and Facility Deficiencies** The facility lacks suitable size and construction for proper operations. The quality unit failed to demonstrate control over differential pressure in the aseptic processing core, with out-of-specification pressure readings during qualification activities (e.g., Grade D Room at 56.25 Pa,