FDA 483 - Eugia Pharma Specialities Limited - February 20, 2018

This FDA Form 483 details observations from an inspection, citing multiple deficiencies in the facility's operations and quality systems.

**Facility and Operations:** The inspection involved the manufacture of "REDACTED injection" in aseptic processing areas, including a vial washer and sterilizer, and a semi-finished product storage area.

**Violations and Observations:** * **Aseptic Processing Area Deficiencies:** Dirty "REDACTED" with black stains were observed on the filling machine during set-up and filling preparation for lot #REDACTED. Management was informed but took no action, and the dirty equipment remained in use. * **Equipment Cleaning and Maintenance:** "REDACTED" on the filling machine, used for aseptic interventions in the Grade A zone, had obvious built-up dirt and stains. These "REDACTED" had been in use since June 2017. * **Equipment Design and Qualification:** The qualification of the vial washer (Eq. Id. # L-PR-QASHM-001) and "REDACTED" for washing and sterilizing "REDACTED mL" vials was inadequate. * The vial washer qualification failed to demonstrate bioburden removal from "REDACTED mL" glass vials. * Qualification studies used a statistically unsound number of vials (less than 1% of a commercial lot size of "REDACTED" vials) to demonstrate cleaning and