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Mercator Medsystems, Inc., Emeryville, CA – FDA Inspections

Inspection records and compliance data for Mercator Medsystems, Inc. in Emeryville, California. 5 FDA inspections on record, 1 Form 483, last inspected March 11, 2026.

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Company Profile

This profile covers Mercator Medsystems, Inc. based in Emeryville, California, United States.

FDA Inspection History

FDA inspections
5
OAI
0
VAI
1
NAI
4
Form 483s
1
Warning letters
0

First inspected October 28, 2010. Last inspected March 11, 2026.

Most cited issue areas

  • Lack of documented justification for not investigating complaint(s)1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
March 11, 2026VAIMedical Devices & Rad Health · Compliance: Medical Devices1306850
January 27, 2020NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1122346
November 3, 2014NAIMedical Devices & Rad Health · Compliance: Devices901345
December 12, 2012NAIMedical Devices & Rad Health · Postmarket Assurance: Devices809228
October 28, 2010NAIMedical Devices & Rad Health · Postmarket Assurance: Devices695968
FDA documents

Form 483s (1)

  • Form 483s · March 11, 2026
People (1)
Kevin T. Le
Person
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Company Information

Name

Mercator Medsystems, Inc.

FEI Number

3004142795

Address

1900 Powell St, Emeryville, California 94608, United States

Country

United States

ID: ce274ad5-3179-4756-afc9-1c8d2fb9dc50

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