FDA 483 - Eugia SEZ Private Limited - February 29, 2024

The FDA Form 483 details observations from an inspection of a facility manufacturing sterile drug products, specifically Injection USP.

**Violations and Observations:**

* **Aseptic Processing Deficiencies:** * Failure to follow procedures EP4-PR-SOP-042 (Aseptic Area Guidelines) and EP4-MB-SOP-028 (Viable Monitoring Program). * Interventions into critical areas during aseptic manufacturing (e.g., removing stuck vials, passing items, cleaning) were not replicated during aseptic process simulations to assess risk. * Operators failed to perform personnel monitoring after interventions into critical areas as mandated by EP4-MB-SOP-028. * Lack of slow and deliberate movements during interventions, contrary to aseptic process simulation techniques. * Failure to sanitize areas after interventions or clear manipulated vials from the line. * No disinfectant efficacy study for tubing used for drug product transfer in the Grade A filling area. * No written procedure for cleaning step ladders and Laminar Airflow Cabinets in Grade A and B areas, and no routine monitoring of these items. Microbial growth was observed on a step ladder sample.

* **Quality Control and Data Integrity Issues:** * Failure to follow SOP-HO-CQA-SOP-072 (Enumeration of Microbial Colonies); a personnel monitoring plate with one