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

Source: https://www.keypedia.com/records/483/sar-med-srl/b08abdc3-2db1-4bee-a3ff-aa777acd2605

> FDA 483 for Sar-Med srl on November 15, 2024. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sar-Med srl
- Inspection Date: 2024-11-15
- Product Type: devices
- Office Name: Baltimore District Office
- Summary: An FDA inspection conducted on November 14-15, 2024, at Sar-Med srl, a medical device manufacturer located in Iglesias, SU, Italy, identified two significant observations. The inspection revealed that the company failed to adequately identify the acceptance status of its products. Specifically, finished medical devices intended for the U.S. market were found labeled as "Sterile" in an external warehouse, despite not having undergone the required sterilization process. These items were not clearly marked as "Non-Sterile," posing a risk of unsterilized products entering distribution. Furthermore, the inspection noted that key personnel lacked the necessary training and experience concerning U.S. FDA regulations pertinent to medical device manufacturers exporting to the U.S. market. This deficiency specifically highlighted a lack of familiarity with 21 CFR Part 807 (Establishment Registration and Device Listing) and 21 CFR Part 820 (Quality System Regulation). These regulations are crucial for ensuring product quality and safety for devices sold in the United States. Sar-Med srl has committed to correcting both identified issues, indicating that a robust corrective action plan is required to bring their operations into compliance with U.S. regulatory standards.

## Related Documents

- [483 - 2024-11-15](https://www.keypedia.com/records/483/sar-med-srl/789e6bf4-a648-4a57-8bd3-017c9c009676)

## Related Officers

- [Milton J. De Jesus](https://www.keypedia.com/people/milton-j-de-jesus/b9ef6f92-913c-430a-9174-6c54a9d692f3)
- [Felix J. Marrero](https://www.keypedia.com/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.keypedia.com/companies/sar-med-srl/4706e260-d162-4a55-95fc-cc7b5b712bd6

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa