# FDA 483 - Healthcare Logistics Systems, LLC, D/B/A Healthcare Logiix Systems - April 02, 2025

Source: https://www.keypedia.com/records/483/healthcare-logistics-systems-llc-dba-healthcare-logiix-systems/7ef23bd7-5244-4686-8be6-927df3b15258

> FDA 483 for Healthcare Logistics Systems, LLC, D/B/A Healthcare Logiix Systems on April 02, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Healthcare Logistics Systems, LLC, D/B/A Healthcare Logiix Systems
- Inspection Date: 2025-04-02
- Product Type: device
- Office Name: Florida District Office
- Summary: An FDA inspection of Healthcare Logistics Systems, LLC, d/b/a Healthcare Logiix Systems, a medical device manufacturer in Coral Springs, FL, revealed significant deficiencies in their quality system. The firm failed to establish essential procedures for complaint handling, corrective and preventive actions, and servicing activities. These findings indicate a fundamental lack of documented processes for critical quality management functions.

## Related Officers

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

Company: https://www.keypedia.com/companies/healthcare-logistics-systems-llc-dba-healthcare-logiix-systems/24080c95-6c42-465e-bb78-7490face80a7

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9