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

Source: https://www.globalkeysolutions.net/records/483/milesman-sl/9d6d94b0-3d89-4247-809f-55758a1f9a63

> FDA 483 for MILESMAN S.L. on February 12, 2016. Product: devices. 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: devices
- Office Name: Center for Devices and Radiological Health
- Summary: During an inspection conducted by the U.S. Food and Drug Administration (FDA) from February 8-12, 2016, medical device manufacturer MILESMAN S.L. in Gijon, Spain, received a Form FDA 483 citing several significant observations related to its quality system and regulatory compliance. The inspection revealed that the company's procedures for corrective and preventive actions (CAPA) were insufficient, lacking details on the type of analysis for identifying quality issues and provisions for verifying the effectiveness of implemented actions. Furthermore, device history records for the Milesman Premium laser system were inadequately maintained, specifically failing to include or reference the location of primary identification labels and acceptance records for laser diodes. Management with executive responsibility was cited for not reviewing the suitability and effectiveness of the quality system with adequate frequency, as evidenced by a lack of documentation for quality objective report reviews. Lastly, MILESMAN S.L. failed to submit required annual reports for its Milesman Premium Laser System for both 2014 and 2015. These observations collectively indicate deviations from the FDA's quality system regulations for medical devices. The company is expected to thoroughly investigate these findings and implement comprehensive corrective actions to ensure full compliance with regulatory requirements.

## Related Documents

- [483 - 2016-02-12](https://www.globalkeysolutions.net/records/483/milesman-sl/392431d5-4452-4b3a-930b-7ec6e6c1fbae)

## Related Officers

- [Plant Manager](https://www.globalkeysolutions.net/people/carlos-mendez/10cd51ee-dd77-4056-a3fd-a3f8a7b6105f)
- [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/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7