# FDA 483 - Alan Neuromedical Technologies - September 13, 2018

Source: https://www.globalkeysolutions.net/records/483/alan-neuromedical-technologies/ba241079-e731-47e0-8fb0-f7f707870122

> FDA 483 for Alan Neuromedical Technologies on September 13, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alan Neuromedical Technologies
- Inspection Date: 2018-09-13
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Alen Neuromedical Technologies in The Woodlands, TX, a medical device specification developer, revealed significant deficiencies in their quality system. Observations included a failure to evaluate and qualify contract manufacturers, inadequate maintenance of complaint files, and a lack of internal quality audits over several years. These issues indicate a need for improved adherence to quality system regulations for medical devices.

## Related Documents

- [483 - 2018-09-13](https://www.globalkeysolutions.net/records/483/alan-neuromedical-technologies/0325d96d-6a18-4408-9c48-62044a11e2ef)

## Related Officers

- [Akbar J. Zaidi](https://www.globalkeysolutions.net/people/akbar-j-zaidi/9cd9ac91-2d4b-4f6f-a975-865342075924)

Company: https://www.globalkeysolutions.net/companies/alan-neuromedical-technologies/35919b37-7b42-411c-84e3-66b9eeb4a70c

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9