FDA 483 - Ferring Microbiome Inc. - June 26, 2025

Ferring Microbiome Inc., a live biotherapeutics manufacturer located in Roseville, Minnesota, underwent an FDA inspection from June 23 to June 26, 2025. The inspection focused on the facility's compliance with safety and quality standards for its commercial drug product, Rebyota. The primary violation identified was the firm's failure to establish a functional system for tracking product distribution, which is essential for facilitating an effective recall if a product is found to be unsafe. Although the company maintains a global procedure for non-conformance management, investigators found that there were no specific localized procedures for executing recall activities. Additionally, the company had failed to perform any mock recalls or system evaluations since beginning commercial production, despite having distributed numerous batches of the drug. These findings were documented under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. Because this Form FDA 483 represents preliminary observations and not a final agency determination, the company is expected to respond to the FDA. Required actions include establishing a formal tracking system for all distributed lots and implementing written procedures to ensure that non-conforming products can be effectively retrieved from the market to protect public health.