# FDA 483 - NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION LLC, dba NEUFIT - September 29, 2021

Source: https://www.keypedia.com/records/483/neurological-fitness-equipment-and-education-llc-dba-neufit/527a308b-eb01-4fa8-8cc7-e7fed4c41c2f

> FDA 483 for NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION LLC, dba NEUFIT on September 29, 2021. 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: 2021-09-29
- 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 (NEUFIT) in Austin, TX, revealed significant deficiencies in their quality system for medical devices. The firm failed to adequately establish and implement procedures for complaint handling, corrective and preventive actions, incoming product acceptance, supplier evaluation, and servicing activities. These issues indicate a broad lack of control over critical aspects of medical device quality and safety.

## Related Documents

- [483 - 2024-07-03](https://www.keypedia.com/records/483/neurological-fitness-equipment-and-education-llc-dba-neufit/3c2f1d07-c2c0-4ec6-a445-de31259b107c)

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

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