# FDA 483 - SterCUBE Surgical Systems LLC - March 17, 2023

Source: https://www.keypedia.com/records/483/stercube-surgical-systems-llc/58fde35a-3a8e-4578-9140-2f7f35514d90

> FDA 483 for SterCUBE Surgical Systems LLC on March 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SterCUBE Surgical Systems LLC
- Inspection Date: 2023-03-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: SteriCube, LLC, a manufacturer of Class II Multiple Tray Sterilization Systems in Gulfport, FL, was inspected by the FDA. The inspection revealed one observation concerning inadequately established procedures for corrective and preventive actions (CAPA). Specifically, the firm's CAPA procedure lacked requirements for standardized analysis of quality data and comprehensive documentation of CAPA activities.

## Related Officers

- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.keypedia.com/companies/stercube-surgical-systems-llc/d91736e8-3a32-4c0b-8996-09eba105188b

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