# FDA 483 - Mako Surgical Corporation - February 23, 2018

Source: https://www.globalkeysolutions.net/records/483/mako-surgical-corporation/8c343385-a515-4af2-b5dc-5063a307b925

> FDA 483 for Mako Surgical Corporation on February 23, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mako Surgical Corporation
- Inspection Date: 2018-02-23
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Mako Surgical Corporation in Davie, FL, revealed two significant issues. The firm failed to adequately document corrective and preventive action (CAPA) activities, specifically regarding the verification and validation of planned actions. Additionally, procedures for ensuring purchased products conform to requirements were not fully implemented, as evidenced by missing supplier documentation for a contract manufacturer.

## Related Officers

- [David M. Wilkinson](https://www.globalkeysolutions.net/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)
- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.globalkeysolutions.net/companies/mako-surgical-corporation/b3dee03a-730e-4f79-855f-f0d128e4dd0f

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6