# FDA 483 - Neurolign USA, Llc - July 02, 2019

Source: https://www.globalkeysolutions.net/records/483/neurolign-usa-llc/86fc336f-e25d-4aab-bbce-ccde509f7d91

> FDA 483 for Neurolign USA, Llc on July 02, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neurolign USA, Llc
- Inspection Date: 2019-07-02
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: Neuro Kinetics, Inc. in Pittsburgh, PA, a medical device manufacturer, was cited by the FDA for several quality system deficiencies. The inspection revealed inadequate design validation for pediatric use of their Neuro-Otologic Test Center system and a lack of established acceptance criteria for these validation activities. Additionally, the firm's procedures for controlling non-conforming product and for the acceptance of incoming materials were found to be inadequately established.

## Related Documents

- [483 - 2022-10-13](https://www.globalkeysolutions.net/records/483/neurolign-usa-llc/00cce877-9680-45cd-bc48-b5ec84ee116f)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)

Company: https://www.globalkeysolutions.net/companies/neurolign-usa-llc/53c20675-c3fd-49f6-b135-907b154e5e47

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8