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1302198

Indilab, Inc. — FEI 1450962

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 9, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Franklin Park, IL (United States)

Facility

Other inspections at this facility

  • 1191439 (NAI Tue Nov 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073332 (NAI Wed Nov 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991812 (NAI Mon Nov 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 837256 (NAI Mon Jun 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 716504 (NAI Mon Mar 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23099ISO 13485:2016 Clause 7.3.2Design and development of product not planned and controlled
63621 CFR 803.17(b)(2)Reports and information documentation