# FDA 483 - MILESMAN S.L. - February 12, 2016

Source: https://www.globalkeysolutions.net/records/483/milesman-sl/392431d5-4452-4b3a-930b-7ec6e6c1fbae

> FDA 483 for MILESMAN S.L. on February 12, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MILESMAN S.L.
- Inspection Date: 2016-02-12
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MILESMAN S.L. in Gijon, Spain, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection found inadequate procedures for nonconformance handling, complaint evaluation, and corrective and preventive actions. Additionally, issues were noted with device history records, management review of the quality system, and the failure to submit required annual reports for their Milesman Premium Laser System.

## Related Documents

- [483 - 2016-02-12](https://www.globalkeysolutions.net/records/483/milesman-sl/9d6d94b0-3d89-4247-809f-55758a1f9a63)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/milesman-sl/87a722e8-0ecc-4791-9c8b-41b990e9d3a4

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd