# FDA 483 - sarmed srl - November 15, 2024

Source: https://www.keypedia.com/records/483/sarmed-srl/25b39787-7b71-4730-8140-41919559b4f2

> FDA 483 for sarmed srl on November 15, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: sarmed srl
- Inspection Date: 2024-11-15
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: Sar-med srl, a medical device manufacturer, was cited with two observations during an FDA inspection. The firm failed to properly identify the acceptance status of medical devices, specifically labeling unsterilized products as "Sterile" without proper "Non-Sterile" identification. Additionally, personnel lacked adequate training and experience regarding USFDA regulations for medical device manufacturing and export.

## Related Officers

- [Felix J. Marrero](https://www.keypedia.com/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.keypedia.com/companies/sarmed-srl/b8654fcc-a76d-4f36-ae1d-e179337213d8

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8