# FDA 483 - FloSpine, LLC - November 18, 2022

Source: https://www.globalkeysolutions.net/records/483/flospine-llc/b801796b-0b96-43be-a26a-f488931e7833

> FDA 483 for FloSpine, LLC on November 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FloSpine, LLC
- Inspection Date: 2022-11-18
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: FloSpine, LLC, a medical device manufacturer in Boca Raton, FL, received two observations during an FDA inspection. The firm failed to adequately investigate device complaints, specifically concerning a Panama Cervical Plate system, and did not properly evaluate a new supplier for this critical device. These deficiencies led to multiple non-conformances and indicate significant issues in the firm's quality system regarding complaint handling and supplier management.

## Related Officers

- [Gisselle I. Sensebe](https://www.globalkeysolutions.net/people/gisselle-i-sensebe/fbf83976-9888-44c0-a381-1993a933df4a)

Company: https://www.globalkeysolutions.net/companies/flospine-llc/176eb880-b349-4042-86d5-dddeee7a6a01

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