# FDA 483 - Ambco Electronics, Incorporated - October 15, 2021

Source: https://www.keypedia.com/records/483/ambco-electronics-incorporated/f2f5150c-afa9-4655-9cec-7a70885632a8

> FDA 483 for Ambco Electronics, Incorporated on October 15, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ambco Electronics, Incorporated
- Inspection Date: 2021-10-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Ambco Electronics, Incorporated in Tustin, CA, a manufacturer of Class II audiometric devices, was cited for failing to establish a complete design history file (DHF) for its 1000+ and 1000+ P product lines. This critical omission means the firm lacks documentation demonstrating proper design development, including design review, verification, validation, software validation, and risk analysis, as required by their own procedures and regulatory standards. This is a significant quality system deficiency impacting product safety and effectiveness.

## Related Officers

- [investigator](https://www.keypedia.com/people/juanita-banuelos/b8b581ef-b9f3-4d77-a9fa-691223dbb7f4)
- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/ambco-electronics-incorporated/1a2b1c06-31d8-499a-b6f7-3790a0d98d37

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6