Drug factory · FDA FEI 3006067100
Eurofins BioPharma Product Testing ENCO, LLC
4810 Executive Park Ct, Suite 110, Jacksonville, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 25, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2016: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Miltefosine | Tests it | Eton Pharmaceuticals, Inc. | 71863-135 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 25, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| May 4, 2016 | 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.
Sep 25, 2025 inspection
- Written records kept in individual logs 21 CFR 211.182
Written records of major equipment use are not included in individual equipment logs.
Registered with FDA for: analysis.