Company
United StatesBionique Testing Laboratories LLC, Saranac Lake, NY – FDA Inspections
Inspection records and compliance data for Bionique Testing Laboratories LLC in Saranac Lake, New York. 6 FDA inspections on record, last inspected January 15, 2026.
Company Profile
This profile covers Bionique Testing Laboratories LLC based in Saranac Lake, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Unclassified
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected February 3, 2010. Last inspected January 15, 2026.
Most cited issue areas
- SOPs not followed / documented1 inspection
- Test devices not meeting specifications1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 15, 2026 | Not classified | Human Drugs | 1300474 |
| October 20, 2025 | Not classified | Biologics | 1290846 |
| September 4, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1129842 |
| April 22, 2015 | NAI | Human Drugs · Drug Quality Assurance | 923594 |
| July 26, 2012 | VAI | Human Drugs · Drug Quality Assurance | 795641 |
| February 3, 2010 | NAI | Human Drugs · Drug Quality Assurance | 645984 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bionique Testing Laboratories LLC
FEI Number
1318709
Address
156 Fay Brook Dr, Saranac Lake, New York 12983, United States
Country
United States
ID: 5ff35d77-a641-4c19-be01-51977e5fa9da