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

Source: https://www.keypedia.com/records/483/neurotris-inc-dba-a1-engineering/054f1f8f-0dd3-49a7-9ed9-c28eafed435d

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

---

## Details

- Record Type: 483
- Company Name: Neurotris, Inc. dba A1 Engineering
- Inspection Date: 2023-04-25
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Neurotris, Inc. dba A1 Engineering in Irvine, CA, was inspected by the FDA from April 4-25, 2023. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning design change control, corrective and preventive actions, non-conforming product control, and purchasing procedures for medical devices. These issues indicate a lack of adequate procedures and documentation for critical manufacturing and quality processes.

## Related Documents

- [483 - 2023-04-25](https://www.keypedia.com/records/483/neurotris-inc-dba-a1-engineering/93dd239f-9aa1-4d8c-8f96-c6514f817574)
- [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/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6