# FDA 483 - Mercator Medsystems, Inc. - March 11, 2026

Source: https://www.keypedia.com/records/483/mercator-medsystems-inc/0be1294c-de95-40c5-a5f9-c2788604340d

> FDA 483 for Mercator Medsystems, Inc. on March 11, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mercator Medsystems, Inc.
- Inspection Date: 2026-03-11
- Product Type: device
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Mercator Medsystems, Inc. in San Leandro, CA, from March 5-11, 2026, revealed a significant deficiency in the firm's complaint handling procedures. The company failed to adequately implement its complaint investigation process, specifically by not investigating all complaints or documenting the rationale when an investigation was not conducted. This indicates a lapse in ensuring device performance and reliability.

## Related Officers

- [Kevin T. Le](https://www.keypedia.com/people/kevin-t-le/cf8b5086-f585-4dd5-9f5c-f082b8a340f4)

Company: https://www.keypedia.com/companies/mercator-medsystems-inc/ce274ad5-3179-4756-afc9-1c8d2fb9dc50

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df