FDA 483 - EUGIA Pharma Specialities Limited - May 03, 2024

This FDA Form 483 details observations from an inspection of a pharmaceutical manufacturing facility. The facility produces sterile drug products, including injections and bulk APIs.

**Observation 1: Procedures to prevent microbiological contamination are not established and followed.** * During aseptic filling, personnel behavior procedures (EP2-PRD-SOP-002) and line-specific intervention procedures were not followed. * Operators reached over the line, blocking laminar airflow, during assembly and filling of Injection, a practice linked to a contaminated vial in a 2022 media fill. * Non-sterile tools were used for interventions, and operators placed hands/arms near sterile product. * Manual manipulations during sterile canister change-outs involved operators reaching over the filling line and exposed stoppers. * Operators touched open vials with non-sterile equipment, and these vials were subsequently filled. * Operators used non-sterile equipment directly over sterile stoppers and surfaces. * An operator's sterile gown had a hole during cleaning in Grade A/B areas. * Sterile canisters were placed on a stool, not the designated cart, disrupting laminar airflow. * During bulk API filling, operators leaned over sterile product and primary closures, disrupting laminar airflow.

**Observation 2: Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process.** * A repetitive, manually