FDA 483 - Sar-Med srl - November 15, 2024

An FDA inspection of Sar-Med srl, a medical device manufacturer in Iglesias, SU, Italy, conducted from November 14-15, 2024, identified two critical observations. The first observation indicated inadequate control over product acceptance status. Specifically, finished medical devices intended for the US market were found labeled as "Sterile" but had not undergone the required sterilization process and were not clearly identified as "Non-Sterile." This suggests a lack of established procedures to differentiate between sterile and non-sterile products, posing a significant risk of distributing unsterilized devices.

The second observation revealed that key personnel involved in operations lacked sufficient training and experience regarding USFDA regulations pertinent to medical device manufacturers and contract manufacturers exporting to the United States. This included a lack of familiarity with 21 CFR Part 807 (Establishment Registration and Device Listing) and 21 CFR Part 820 (Quality System Regulation). Both findings highlight significant deviations from regulatory requirements. Sar-Med srl acknowledged the observations and committed to implementing corrective actions to address these deficiencies.