# FDA 483 - Neuro-Fitness LLC - October 18, 2022

Source: https://www.keypedia.com/records/483/neuro-fitness-llc/e9f88f2b-b9aa-4ce8-8fba-b88a6e77ce9b

> FDA 483 for Neuro-Fitness LLC on October 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neuro-Fitness LLC
- Inspection Date: 2022-10-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Neuro-Fitness LLC, a manufacturer in Fall City, WA, was inspected by the FDA and received a Form 483 with two observations. The inspection revealed significant deficiencies in the firm's complaint handling procedures, including inadequate MDR reportability evaluations, lack of a complaint log, and improper complaint closure. Additionally, the firm failed to adequately implement its internal quality audit procedures, lacking documentation for required audits.

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.keypedia.com/companies/neuro-fitness-llc/6c28cc5e-6c38-4e15-a762-7cfc16def455

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822