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1306850

Mercator Medsystems, Inc. — FEI 3004142795

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 11, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
San Leandro, CA (United States)

Facility

Other inspections at this facility

  • 1122346 (NAI Mon Jan 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 901345 (NAI Mon Nov 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 809228 (NAI Wed Dec 12 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 695968 (NAI Thu Oct 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23216ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)