Mercator Medsystems, Inc.March 11, 2026

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

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Record Details

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.

Company: Mercator Medsystems, Inc.
Inspection Date: March 11, 2026
Product Type: Device
Office: San Francisco District Office
Person: Kevin T. Le

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ID · 0be1294c-de95-40c5-a5f9-c2788604340d