# FDA 483 - Merchsource LLC - October 22, 2025

Source: https://www.keypedia.com/records/483/merchsource-llc/e220b6fd-86ec-491b-b114-dba652cd9eb7

> FDA 483 for Merchsource LLC on October 22, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merchsource LLC
- Inspection Date: 2025-10-22
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Merchsource LLC in Irvine, CA, from October 14-22, 2025, revealed significant deficiencies in their quality system as a medical device specification developer. The firm lacked adequately established procedures for complaint handling, corrective and preventive actions, device history records, design history files, and document control. These issues indicate a systemic failure to maintain proper documentation and control over their medical device processes.

## Related Officers

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

Company: https://www.keypedia.com/companies/merchsource-llc/f8e29531-b65d-4cba-9392-978f613f64cf

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