FDA 483 - Rovi Pharma Industrial Services S.A. - September 22, 2023

During an inspection conducted from September 18-22, 2023, the U.S. Food and Drug Administration issued a Form 483 to Rovi Pharma Industrial Services S.A., a sterile manufacturer in San Sebastian De Los Reyes, Spain. This document outlines significant observations indicating potential deviations from good manufacturing practices in their quality control and equipment management systems. One primary observation highlighted the failure to thoroughly investigate unexplained discrepancies. This included instances where environmental monitoring plates were not read or recorded for up to 21 days post-incubation, lacking a comprehensive assessment of the impact on results. Furthermore, an aberrant analytical result was not adequately investigated, with repeat testing exceeding established limits and the broader impact of potential contamination on other samples left unaddressed. A second observation detailed deficiencies in procedures for cleaning and maintaining equipment, specifically regarding the protection of clean materials from contamination. Materials were moved into classified manufacturing areas before meeting required sanitization hold times, and there was an absence of clear guidelines defining maximum hold times for sanitized materials or when re-sanitization is necessary. As a result, Rovi Pharma Industrial Services S.A. is required to provide a formal response to the FDA, detailing corrective and preventive actions to resolve these identified issues and ensure compliance with regulatory standards for sterile drug manufacturing.