FDA 483 - Centro de Construccion de Cardioestimuladores del Uruguay SA - August 18, 2022

During an FDA inspection conducted from August 15-18, 2022, Centro de Construccion de Cardioestimuladores del Uruguay SA, a contract manufacturer and sterilizer, received a Form FDA-483. The primary observation noted an issue with the suitability of critical test equipment. Specifically, investigators found two differential amplifiers, used for troubleshooting a Class III medical device (ReActiv8), with expired calibration labels dated October 2021 and June 2022. Furthermore, these uncalibrated devices lacked the necessary "out of service" labeling, which violates the company's own internal procedure (Pr12, Rev.10, Section 5.7) for controlling inspection, measurement, and test equipment. This deficiency is critical for maintaining product quality and compliance under the Federal Food, Drug, and Cosmetic Act. The company indicated a "promised to correct" action for this observation. The FDA also emphasized the firm's broader responsibility to conduct ongoing internal self-audits to identify and rectify all quality system deficiencies to ensure continued regulatory compliance.