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

An FDA inspection of Centro de Construccion de Cardioestimuladores del Uruguay SA, a contract manufacturer and sterilizer in Montevideo, Uruguay, revealed a significant quality system deficiency. The firm was cited for using test equipment with out-of-date calibration labels for troubleshooting a Class III medical device, indicating a failure to ensure equipment suitability for its intended purpose.