# FDA 483 - NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION LLC, dba NEUFIT - July 03, 2024

Source: https://www.keypedia.com/records/483/neurological-fitness-equipment-and-education-llc-dba-neufit/3c2f1d07-c2c0-4ec6-a445-de31259b107c

> FDA 483 for NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION LLC, dba NEUFIT on July 03, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION LLC, dba NEUFIT
- Inspection Date: 2024-07-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of NEUROLOGICAL FITNESS EQUIPMENT AND EDUCATION LLC, dba NEUFIT, in Austin, TX, revealed significant deficiencies in its complaint handling system. The firm failed to promptly review, evaluate, and investigate MDR-reportable complaints, with critical documentation lacking required signatures. Additionally, procedures for receiving, reviewing, and evaluating complaints were not adequately established, leading to insufficient documentation of oral complaints, MDR reportability evaluations, and investigative actions.

## Related Documents

- [483 - 2021-09-29](https://www.keypedia.com/records/483/neurological-fitness-equipment-and-education-llc-dba-neufit/527a308b-eb01-4fa8-8cc7-e7fed4c41c2f)

## Related Officers

- [Katlin N. Stubbs](https://www.keypedia.com/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)

Company: https://www.keypedia.com/companies/neurological-fitness-equipment-and-education-llc-dba-neufit/806bfe0e-ec0c-4cc2-b5b0-9cec5b4b41b1

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab