# FDA 483 - Neurotris, Inc. dba A1 Engineering - April 25, 2023

Source: https://www.keypedia.com/records/483/neurotris-inc-dba-a1-engineering/93dd239f-9aa1-4d8c-8f96-c6514f817574

> FDA 483 for Neurotris, Inc. dba A1 Engineering on April 25, 2023. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neurotris, Inc. dba A1 Engineering
- Inspection Date: 2023-04-25
- Product Type: devices
- Office Name: Los Angeles District Office
- Summary: During an FDA inspection conducted from April 4 to April 25, 2023, Neurotris, Inc. dba A1 Engineering, a medical device manufacturer, received a Form FDA 483 detailing significant quality system deficiencies. The inspection identified four primary observations requiring corrective action.

Firstly, the company lacked established procedures for design changes. Specifically, modifications to their SX 3800 and SX 4500 devices were implemented without proper documentation through engineering change requests or validation, contradicting the firm's own procedures.

Secondly, corrective and preventive action (CAPA) procedures were inadequate. Documentation was missing to verify the implementation and effectiveness of corrective actions, such as a fix for an LED issue on the SX-4500. Additionally, Neurotris, Inc. failed to analyze customer complaints to identify recurring product problems, a key aspect of an effective CAPA system.

Thirdly, controls for non-conforming products were insufficient. A device (SX3800) with a known non-conformance that required rework was distributed, yet its associated non-conformance report remained open with no recorded evidence of rework or re-evaluation.

Finally, the company's procedures for ensuring purchased products and services met specified requirements were deficient. There was no clear outline of control over suppliers, nor were there written specifications or quality requirements for critical components, including a Class II device, the Pico Toner.

Neurotris, Inc. dba A1 Engineering committed to correcting all identified observations. These findings underscore the necessity for the firm to implement robust quality system processes in compliance with federal medical device regulations.

## Related Documents

- [483 - 2023-04-25](https://www.keypedia.com/records/483/neurotris-inc-dba-a1-engineering/054f1f8f-0dd3-49a7-9ed9-c28eafed435d)
- [WARNING_LETTER - 2023-04-25](https://www.keypedia.com/records/warning_letter/neurotris-inc-dba-a1-engineering/b0c28870-c95c-4f1a-8b8f-cd77f2356438)

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/neurotris-inc-dba-a1-engineering/40d37d89-fab5-4cbe-b56a-d62ce0e8fbbb

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b