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795641

Bionique Testing Laboratories LLC — FEI 1318709

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 26, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
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))
  • 1290846 (NAI Mon Oct 20 2025 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))
  • 645984 (NAI Wed Feb 03 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
361521 CFR 211.160(b)(4)Test devices not meeting specifications