FDA 483 - Merck Serono SA (Vevey) - April 06, 2023

An FDA Form 483 was issued to Merck Serono SA (Vevey) following an inspection of their drug substance manufacturing facility in Corsier-Sur-Vevey, Switzerland, conducted from March 30 to April 6, 2023. The key observation centered on the company's failure to adequately monitor its water purification system to ensure the water used in drug manufacturing was of appropriate quality. Specifically, FDA investigators identified several undocumented water leaks from critical components of the water purification system, including tanks X-57310, X-57520, and X-57530. These systems are vital for supplying water to various production suites involved in manufacturing. A notable instance highlighted was a leak from Tank X-57310, which was reportedly discovered on March 8, 2023, but was neither documented nor had a formal work order or deviation initiated. These findings indicate a deficiency in the firm's quality control over its manufacturing environment, specifically concerning the integrity and monitoring of its water supply systems. Such issues are critical under the Federal Food, Drug, and Cosmetic Act, as they can compromise the quality and safety of drug substances. Merck Serono SA is now expected to provide a comprehensive response detailing corrective and preventive actions to address these observations and ensure ongoing compliance with regulatory standards.