FDA 483 - Sterigenics Belgium (Fleurus) S.A. - November 07, 2024

During an inspection conducted from November 4 to November 7, 2024, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to Sterigenics Belgium (Fleurus) S.A., a contract sterilizer located in Fleurus, Belgium. The report, addressed to General Manager Giuseppe Ritaccio, outlined significant observations concerning the firm's quality system, specifically its corrective and preventive action (CAPA) procedures. The primary finding was that procedures for corrective and preventive actions had not been adequately established. Detailed observations included deficiencies in managing existing CAPAs. For instance, CAPA CA 6444, initiated in April 2021 for an identified training issue, lacked documented corrective actions addressing its root cause. Similarly, CAPA CA 6709, opened in 2021 due to an internal audit finding inadequate CAPA follow-up, did not include verification that previously cited CAPAs had been reviewed for correction. Furthermore, CAPA CA 7824, stemming from a July 2023 external audit, highlighted that a critical process record was not included in work order documentation, and Sterigenics Belgium had not implemented corrective action for this identified issue, nor did it record incidents of process interruption in work orders. These observations indicate a failure to adequately implement and maintain essential quality system processes, as required by FDA regulations. The FDA 483 serves as a formal notification of these objectionable conditions, requiring Sterigenics Belgium to conduct thorough internal reviews and implement comprehensive corrective actions to ensure full compliance with regulatory standards.