FDA 483 - Pharmathen International S.A. - November 21, 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 processes critical for maintaining the sterility of drug products. Key observations included the failure to establish and adhere to procedures preventing microbiological contamination. Investigations into microbial contamination identified human-derived microorganisms such as Staphylococcus and Corynebacterium but failed to pinpoint specific root causes or implement effective preventive measures.

Specific issues observed during the inspection included inadequate aseptic techniques, such as operators' heads and hands breaching sterile barriers, improper handling of equipment, and the reuse of sterilization covers without established procedures. These practices were noted during the aseptic filling processes for various injection batches, highlighting lapses in maintaining sterile environments.

The FDA's observations underscore the need for Pharmathen International S.A. to develop and enforce robust aseptic procedures and corrective actions to address these deficiencies. The company is expected to identify root causes of contamination, improve aseptic techniques, and ensure compliance with regulatory standards to prevent future occurrences. Failure to address these issues could lead to further regulatory actions by the FDA.