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FDA Inspection 1290846 — Bionique Testing Laboratories LLC

Bionique Testing Laboratories LLC — FEI 1318709

The FDA completed an inspection of Bionique Testing Laboratories LLC on October 20, 2025 in Saranac Lake, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). Product area: Biologics.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
October 20, 2025
Fiscal Year
2026
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Saranac Lake, NY (United States)

Facility

Other inspections at this facility

  • 1300474 (NAI Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1129842 (NAI Fri Sep 04 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923594 (NAI Wed Apr 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 795641 (VAI Thu Jul 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 645984 (NAI Wed Feb 03 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources