# FDA 483 - Portal 724 LLC - June 05, 2025

Source: https://www.keypedia.com/records/483/portal-724-llc/5fbb51f2-adc6-482e-bb14-63d1917cdf40

> FDA 483 for Portal 724 LLC on June 05, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Portal 724 LLC
- Inspection Date: 2025-06-05
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Portal 724 LLC, a specification developer in Little Falls, NJ, received a Form FDA 483 with four observations during an inspection. The firm failed to adequately establish and implement critical quality system procedures, including complaint handling, medical device reporting (MDR), corrective and preventive actions (CAPA), and purchasing controls. Two of these failures, MDR procedures and CAPA, were noted as recurring observations, indicating persistent issues with their quality system.

## Related Documents

- [483 - 2023-09-21](https://www.keypedia.com/records/483/portal-724-llc/e5e7ffb5-a5ca-4b6a-8dd0-3e83ebda5739)

## Related Officers

- [Esteban Beltran](https://www.keypedia.com/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)
- [Nakesh N. Gomanie](https://www.keypedia.com/people/nakesh-n-gomanie/cfffa8e1-fdfb-4bc4-a845-44bcd593c9c7)

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