FDA WARNING_LETTER - Fagron Group B.V. - November 05, 2025

The FDA issued a warning letter to Fagron BV following an inspection of its Canton, Massachusetts facility (operating as Fagron Sterile Services) conducted between October 9 and November 5, 2025. As a registered outsourcing facility under the Federal Food, Drug, and Cosmetic Act, the company is required to meet strict safety and quality standards. Investigators identified significant violations of Current Good Manufacturing Practice (CGMP) and the existence of insanitary conditions that jeopardize product sterility. Key issues included improper aseptic techniques that disrupted clean airflow, inadequate environmental monitoring, and a failure to maintain the facility"s physical integrity, such as repairing chipped paint and floor damage. Most notably, the firm continued using IV bags from a supplier despite documented defects and leaks, failing to establish a definitive root cause for these failures. Although Fagron BV initiated a voluntary recall and proposed several improvements, the FDA determined these actions were insufficient due to a lack of supporting documentation and inadequate risk assessments. The company is required to submit a detailed corrective action plan within 15 working days. Additionally, the FDA strongly recommends that management hire an independent consultant to perform a comprehensive evaluation of their sterile drug manufacturing operations.