FDA EIR - Sterigenics Belgium (Fleurus) S.A. - May 24, 2017

An FDA inspection of Sterigenics Belgium (Fleurus) S.A. was conducted from May 22-24, 2017. The company functions as a contract sterilizer for medical devices and a veterinary drug product destined for the U.S. market, thus falling under FDA regulatory purview. While the inspection concluded without the issuance of an FDA Form 483 Inspectional Observations, several areas requiring attention were discussed with the firm's management. These observations included data integrity concerns related to their dosimetry reading software, which allowed values to be overwritten without preserving historical data. The firm had initiated a Corrective and Preventive Action (CAPA #CA-778) and was in the process of implementing a new software system. Another point of discussion centered on the quality system's inefficiency in linking related investigations and CAPAs, which resulted in the duplication of corrective actions for similar issues across different customers. A deficiency in complaint handling was also noted, as a damage report was not included for a U.S. customer's damaged product, prompting CAPA #CA-73. Furthermore, vendor-supplied calibration certificates were found to lack comprehensive details, specifically regarding the calibration of reference standards and their expiration dates. Management was advised to prioritize enhancing electronic system compliance with 21 CFR Part 11 and data integrity principles, improving the interconnectedness of investigation and CAPA documentation, and ensuring that all vendor calibration certificates are complete and accurate.