Home / Inspections / 1267823

1267823

Paragon 28, Inc. — FEI 3008650117

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 24, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Englewood, CO (United States)

Additional Details

Postmarket Audit Inspections

Facility

Other inspections at this facility

  • 1214506 (NAI Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1176976 (NAI Wed Jun 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007606 (NAI Tue Apr 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 856673 (NAI Tue Nov 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures