# FDA 483 - Integrity United Inc - September 25, 2025

Source: https://www.keypedia.com/records/483/integrity-united-inc/6ec197d7-68d0-4daf-8a52-38eb38a0f240

> FDA 483 for Integrity United Inc on September 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Integrity United Inc
- Inspection Date: 2025-09-25
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Integrity United Inc, a specification developer in Anaheim, CA, was inspected by the FDA and received a Form 483 with nine observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures and documentation for complaint handling, CAPA, purchasing controls, device history records, UDI labeling, design history files, document control, internal audits, and management review. Several observations were repeats from a previous inspection, indicating persistent systemic issues.

## Related Documents

- [483 - 2021-10-18](https://www.keypedia.com/records/483/integrity-united-inc/b79f94d2-e238-4b2a-9ca0-de6bff31a8a5)

## Related Officers

- [Jae H. Lee](https://www.keypedia.com/people/jae-h-lee/ce701294-2a54-48f2-8a34-e93231bc2d88)

Company: https://www.keypedia.com/companies/integrity-united-inc/5ab5d3fe-c9d4-4972-b2f9-403a52ed153c

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