FDA WARNING_LETTER - Pharmathen International S.A. - November 21, 2025

Pharmathen International S.A. received an FDA warning letter following an inspection from November 10 to 21, 2025, at its manufacturing facility in Greece. The agency identified significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering the company’s drug products adulterated under the Federal Food, Drug, and Cosmetic Act. The primary issues involve critical failures in sterile manufacturing, including inadequate airflow protections in aseptic filling areas and recurring microbial contamination. Investigators observed poor employee practices and found that the facility lacked proper air pressure controls to prevent contaminants from entering cleanrooms. Furthermore, the company failed to thoroughly investigate failed test results and high levels of visible particles in finished drugs. Documentation practices were also found to be deficient, with missing raw data and non-contemporaneous record-keeping raising serious data integrity concerns. In response to these findings, Pharmathen has suspended manufacturing for the U.S. market and initiated voluntary recalls of affected injectable products. The FDA has also placed the firm on an import alert. To remediate these violations, Pharmathen must engage independent consultants to conduct a comprehensive audit and a retrospective data integrity review. The company is required to provide the FDA with a detailed corrective action plan, updated airflow studies, and a robust risk assessment of its entire aseptic processing operation. Resumption of manufacturing will require formal notification to the FDA and a successful follow-up inspection to verify compliance.