# FDA 483 - Portal 724 LLC - September 21, 2023

Source: https://www.keypedia.com/records/483/portal-724-llc/e5e7ffb5-a5ca-4b6a-8dd0-3e83ebda5739

> FDA 483 for Portal 724 LLC on September 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Portal 724 LLC
- Inspection Date: 2023-09-21
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Portal 724 LLC in Secaucus, NJ, was cited for significant deficiencies in its quality system, particularly concerning complaint handling, Medical Device Reporting (MDR), and design controls. The inspection revealed a failure to establish and implement critical procedures, leading to unfiled MDRs for serious injuries and a patient death associated with their medical devices. These issues indicate a severe lack of control over product quality and patient safety.

## Related Documents

- [483 - 2025-06-05](https://www.keypedia.com/records/483/portal-724-llc/5fbb51f2-adc6-482e-bb14-63d1917cdf40)

## Related Officers

- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.keypedia.com/companies/portal-724-llc/04278080-fb26-4cf1-a1f5-24474832a162

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248