# FDA 483 - Forsure Medical Products, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/forsure-medical-products-llc/0bfee43b-dfc3-4e5c-8a82-5ec4fd03cc91

> FDA 483 for Forsure Medical Products, LLC on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Forsure Medical Products, LLC
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Forsure Medical Products, LLC in Doral, FL, conducted in August 2023, identified a significant issue regarding the firm's complaint handling system. The company failed to maintain complaint files and properly implement its product complaint handling procedure, leading to inadequate processing, review, evaluation, and investigation of device-related complaints. This indicates a breakdown in critical quality system controls for medical devices.

## Related Officers

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

Company: https://www.keypedia.com/companies/forsure-medical-products-llc/972c6e74-518f-410d-98a1-635c8c94106a

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