Drug factory · FDA FEI 1318709
Bionique Testing Laboratories LLC
156 Fay Brook Drive, Saranac Lake, NY, United States
No problems found at FDA's last inspection, Jan 15, 2026.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2010: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Olipudase Alfa | Tests it | Genzyme Corporation | 58468-0050, 58468-0051 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 15, 2026 | No problems found | Drug Quality Assurance | — |
| Sep 4, 2020 | No problems found | Drug Quality Assurance | — |
| Apr 22, 2015 | No problems found | Drug Quality Assurance | — |
| Jul 26, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Feb 3, 2010 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 26, 2012 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Test devices not meeting specifications 21 CFR 211.160(b)(4)
Test devices are deficient in that instruments and recording devices not meeting established specifications are used.
Registered with FDA for: analysis.