Pharmathen International S.A. – FDA 483, Nov 10, 2025

The FDA conducted an inspection of Pharmathen International S.A., a drug manufacturing facility located in Rodopi, Greece, from November 10 to November 21, 2025. The inspection revealed significant violations related to aseptic processing and contamination control. Key observations included the failure to establish and follow procedures to prevent microbiological contamination in sterile drug products. Investigations into microbial contamination, such as media fill failures and sterility issues, identified human source microorganisms but failed to determine specific root causes or implement effective preventive actions.

The inspection highlighted several procedural lapses, including inadequate aseptic techniques and improper handling of equipment and materials in cleanroom environments. Specific issues observed included operators performing interventions with improper aseptic behavior, such as reaching over sterile surfaces and reusing equipment covers without proper procedures. These practices were linked to environmental monitoring excursions that identified human source microorganisms in critical manufacturing areas.

The FDA requires Pharmathen International S.A. to address these deficiencies by establishing robust aseptic procedures and ensuring compliance with regulatory standards to prevent contamination. The company is expected to investigate the root causes of contamination thoroughly and implement corrective actions to mitigate future risks. Failure to comply may result in further regulatory actions by the FDA.