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FDA Inspection 1006561 — TCI Biotech, USA LLC

TCI Biotech, USA LLC — FEI 3003969912

The FDA completed an inspection of TCI Biotech, USA LLC on March 27, 2017 in American Fork, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 27, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
American Fork, UT (United States)

Facility

Other inspections at this facility

  • 1290458 (VAI Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1191479 (VAI Mon Nov 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007026 (VAI Mon Mar 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 896923 (VAI Wed Sep 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 757352 (NAI Wed Dec 14 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources