# FDA 483 - Apex Medical Technologies, Inc. - January 15, 2026

Source: https://www.keypedia.com/records/483/apex-medical-technologies-inc/49344bd7-4bcd-4f4e-90eb-33f7ace444ce

> FDA 483 for Apex Medical Technologies, Inc. on January 15, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apex Medical Technologies, Inc.
- Inspection Date: 2026-01-15
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Apex Medical Technologies, Inc. in San Diego, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for handling customer complaints, including UDI documentation and investigation rationale. Additionally, their corrective and preventive action (CAPA) procedures were found to be inadequate, specifically regarding root cause analysis, documentation of corrective actions, and verification of effectiveness.

## Related Officers

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

Company: https://www.keypedia.com/companies/apex-medical-technologies-inc/aace9ba3-6b7b-4316-b34c-8160f4ff07c8

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