# FDA 483 - Reflow Medical - March 05, 2026

Source: https://www.keypedia.com/records/483/reflow-medical/d3eaf1d2-1e71-45ab-8e5a-40825c212f0c

> FDA 483 for Reflow Medical on March 05, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reflow Medical
- Inspection Date: 2026-03-05
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Reflow Medical, a medical device manufacturer in Lake Forest, CA, received two observations during an FDA inspection. The firm was cited for not having documented procedures for verifying the effectiveness of preventive actions. Additionally, their criteria for evaluating and selecting suppliers were found to be inadequate, failing to properly assess risk and ensure appropriate quality agreements.

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/reflow-medical/630726f8-9449-4b2b-a8c2-c1b722acac50

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