Pharmathen International S.A. – FDA EIR, Oct 26, 2017

A Pre-Approval Inspection (PAI) of Pharmathen International S.A., a generic pharmaceutical manufacturer located in Sapes, Greece, was conducted by the FDA from October 19 to October 26, 2017. This initial inspection aimed to evaluate the facility's readiness for commercial manufacturing of (b)(4) Capsules and (b)(4) Injection, in accordance with the CPGM 7346.832 regulatory framework for Pre-Approval Inspections. The inspection covered profile classes for modified release capsules (CTR) and sterile-filled small volume parenteral drugs (SVS). At the conclusion, a 3-item FDA-483, Inspectional Observations, was issued to the Plant Manager. Key observations included the use of portable airborne viable samplers in Grade A Restricted Access Barrier Systems (RABS) during sterile filling operations, and the absence of established sampling criteria, alarm set points, and remedial action instructions for non-viable particle excursions in environmental monitoring. Despite these observations, the inspection resulted in a "Voluntary Action Indicated" (VAI) status. The FDA recommended an "acceptable" status for the facility as a finished product manufacturer for the submitted applications, indicating that while observations require voluntary corrective actions from the company, they do not prevent initial approval. No samples were collected, and no refusals were encountered during the inspection.