FDA inspection

Bionique Testing Laboratories LLC: FDA inspection ending Oct 20, 2025

FDA inspection 1290846 · No Action Indicated (NAI) · Saranac Lake, NY

Key facts

Inspection ID 1290846
Firm Bionique Testing Laboratories LLC
FEI number 1318709
Address 156 Fay Brook Dr
City Saranac Lake
State NY
ZIP 12983
Country United States
Fiscal year 2026
Inspection end date Oct 20, 2025
Classification No Action Indicated (NAI)
Project area Human Cellular, Tissue, and Gene Therapies
Product type Biologics

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • No Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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