# FDA 483 - Flextronics America LLC - October 30, 2025

Source: https://www.keypedia.com/records/483/flextronics-america-llc/eddf70a6-958e-4c4e-a619-d34c9470c3ed

> FDA 483 for Flextronics America LLC on October 30, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Flextronics America LLC
- Inspection Date: 2025-10-30
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Flextronics America LLC in Austin, TX, a Class II medical device manufacturer, identified three significant observations. The firm failed to adequately validate manufacturing processes for its Continuous Glucose Monitoring system, lacked established procedures for acceptance activities to ensure device functionality, and did not properly document corrective and preventive actions related to device failures and process controls.

## Related Documents

- [WARNING_LETTER - 2025-10-30](https://www.keypedia.com/records/warning_letter/flextronics-america-llc/79531a74-4d23-4d1f-8cc3-19356189a611)

## Related Officers

- [Katherine M. Thames](https://www.keypedia.com/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)
- [Cso](https://www.keypedia.com/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.keypedia.com/companies/flextronics-america-llc/3043bb5b-dacc-4385-99e3-08dc498ee4dc

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9