# FDA 483 - Syntech International, Inc - September 19, 2025

Source: https://www.keypedia.com/records/483/syntech-international-inc/c23a0c72-bc6d-4e5b-bc5b-b3a97fc38208

> FDA 483 for Syntech International, Inc on September 19, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Syntech International, Inc
- Inspection Date: 2025-09-19
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Syntech International, Inc. in Irvine, CA, a manufacturer of MAXAIR devices, was cited for two significant issues during an FDA inspection. The firm failed to adequately maintain complaint files for numerous cable failures and did not register any of its MAXAIR devices on the Global Unique Device Identification Database (GUDID). These observations indicate deficiencies in quality system processes related to complaint handling and device identification.

## Related Officers

- [Jordan I. Abel](https://www.keypedia.com/people/jordan-i-abel/9cdc8877-ab20-4c0c-a17e-a8534d4f13f2)

Company: https://www.keypedia.com/companies/syntech-international-inc/f83b30aa-4538-43dd-834e-ef92c43329ca

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