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1302886

Adler MicroMed, Inc. — FEI 3011412640

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 12, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 1218559 (NAI Thu Aug 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1089915 (NAI Tue Apr 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 974410 (NAI Tue May 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23024ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
23139ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
23151ISO 13485:2016 Clause 7.4.3Purchased product verification activities are inadequate