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1304490

Tessy Plastics Corp. — FEI 1317202

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 20, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Elbridge, NY (United States)

Facility

Other inspections at this facility

  • 1176152 (NAI Thu Jul 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1112307 (NAI Tue Nov 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991783 (VAI Mon Oct 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 795807 (VAI Tue Aug 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 775458 (NAI Tue Dec 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23087ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
23241ISO 13485:2016 Clause 8.3.2Nonconforming product concessions accepted without meeting requirements